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Spectranetics Corporation

United States·US-MF-000018632

Last updated September 17, 2026

Information

Country: United States
Address: 5055, Brandin Court , Fremont, United States
Website: n/a
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: n/a
PRRC Contact: David Horton
EUDAMED SRN: US-MF-000018632
FDA FEI Number: 3005462046
DUNS Number: 151047370

Catalogue (572)

Page 8 of 12

Device	Model / Reference	Registries	Class	Status
Clirpath Turbo Plus Excimer Laser Catheters, Models 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001	K052514	FDA 510(k)	Class II	Active
Spectranetics Quick Cross Catheters, Models 518-032, 518-033, 518034, 518-035, 518-036, 518-037 And 518-038	K033678	FDA 510(k)	Class II	Active
2.5 Mm Turbo Clirpath Excimer Laser Catheter, Model 225-011	K043465	FDA 510(k)	Class II	Active
CavaClear Laser Sheath	DEN210024	FDA 510(k)	Class II	Active
Spectranetics Lld Cs, Model 518-039	K043401	FDA 510(k)	Class II	Active
8fr Turbo Booster, Guide Catheter, 7fr Turbo Booster, Model 518-063, 518-043	K071226	FDA 510(k)	Class II	Active
Clirpath Turbo Excimer Laser Catheter (rx) -0.9mm, (rx) -1.4mm, (rx) -1.7mm, (rx) -2.0mm, Model 310-154, 314-159, 317-15	K071227	FDA 510(k)	Class II	Active
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)	K223472	FDA 510(k)	Class II	Active
Clirpath Turbo Peripheral Catheters	K060012	FDA 510(k)	Class II	Active
Cross-Pilot Turbo Elite Support Catheter	K090913	FDA 510(k)	Class II	Active
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	K172687	FDA 510(k)	Class II	Active
Spectranetics Lead Locking Device (lld) #1, #2, #3 Lister	K990713	FDA 510(k)	Class II	Active
Turbo-Elite Atherectomy Catheters, Turbo Tandem System	K140775	FDA 510(k)	Class II	Active
TightRail Guardian Motorized Dilator Sheath	K212784	FDA 510(k)	Class II	Active
Clirpath Turbo Excimer Laser Catheters	K052296	FDA 510(k)	Class II	Active
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	K180694	FDA 510(k)	Class II	Active
Spectranetics 0.035 Support Catheter, Model 518-028	K022138	FDA 510(k)	Class II	Active
8fr Turbo - Tandem System	K112032	FDA 510(k)	Class II	Active
Spectranetics Turbo-Tandem System	K091299	FDA 510(k)	Class II	Active
Spectranetics Cross-Pilot Turbo Elite Support Catheter	K082559	FDA 510(k)	Class II	Active
Turbo-Power (2.0mm) Laser Atherectomy Catheters	K162561	FDA 510(k)	Class II	Active
Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters	K222837	FDA 510(k)	Class II	Active
Lexipliant Dilator Sheath Set	K133631	FDA 510(k)	Class II	Active
Spectranetics Quick-Cross Support2 Catheters, Models 518-065 And 518-066	K072750	FDA 510(k)	Class II	Active
Clirpath Excimer Laser Catheter	K040067	FDA 510(k)	Class II	Active
Turbo-Tandem System Model 472-110	K094036	FDA 510(k)	Class II	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX060080080	EUDAMED	Class III	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2237-50100	EUDAMEDFDA UDI	Class IIa	Active
AngioSculpt PTCA RX Scoring Balloon Catheter	2200-2015	EUDAMEDFDA UDI	Class III	Active
SightRail Manual Dilator Sheath	555-508	EUDAMEDFDA UDI	Class III	Active
Stellarex 0.014" OTW Drug-coated Angioplasty Balloon	AA14SX035080090	EUDAMED	Class III	Active
Stellarex 0.014" OTW Drug-coated Angioplasty Balloon	AA14SX030080150	EUDAMED	Class III	Active
Turbo-Elite Laser Atherectomy Catheter	420-006	EUDAMEDFDA UDI	Class IIa	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX040150080	EUDAMED	Class III	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX060040135	EUDAMED	Class III	Active
Stellarex 0.014" OTW Drug-coated Angioplasty Balloon	AA14SX025040150	EUDAMED	Class III	Active
Stellarex 0.035" OTW Drug-coated Angioplasty Balloon	A35SX060200080	EUDAMED	Class III	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2249-50200	EUDAMEDFDA UDI	Class IIa	Active
VisiSheath Dilator Sheath	501-016	EUDAMEDFDA UDI	Class III	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2249-60200	EUDAMEDFDA UDI	Class IIa	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2334-8040	EUDAMEDFDA UDI	Class IIa	Active
VisiSheath Dilator Sheath	501-012	EUDAMEDFDA UDI	Class III	Active
VisiSheath Dilator Sheath	501-014	EUDAMEDFDA UDI	Class III	Active
Quick-Cross Capture Guidewire Retriever	519-106	EUDAMEDFDA UDI	Class IIa	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2332-7040	EUDAMEDFDA UDI	Class IIa	Active
AngioSculpt OTW PTA Scoring Balloon Catheter	2290-50100	EUDAMEDFDA UDI	Class IIa	Active
Stellarex 0.014" OTW Drug-coated Angioplasty Balloon	AA14SX040080090	EUDAMED	Class III	Active
AngioSculpt PTCA RX Scoring Balloon Catheter	2200-2010	EUDAMEDFDA UDI	Class III	Active
ELCA Coronary Laser Atherectomy Catheter	120-009	EUDAMEDFDA UDI	Class III	Active
Turbo-Elite Laser Atherectomy Catheter	417-152	EUDAMEDFDA UDI	Class IIa	Active

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FDA Recalls (21)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 10, 2025	Z-1070-2025	—	open, classified	Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could result in problems with deployment and stability of device in vessel after deployment, which may cause failure to resolve dissection, migration of implant, bailout stenting, reintervention, unintended removal of tack devices, and ischemia.
Nov 25, 2024	Z-0680-2025	—	open, classified	Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.
Nov 15, 2023	Z-0509-2024	—	open, classified	Incorrect product labeling. Exterior product box label does not match internal pouch label.
Oct 14, 2022	Z-0221-2023	—	open, classified	Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error is cleared. May result in initiation of treatment delay and/or treatment beyond initial scope and/or unable to treat patient.
Jun 1, 2022	Z-1351-2022	—	open, classified	The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.
Mar 31, 2020	Z-2143-2020	—	terminated	There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction cases may not be aware of this risk. It was determined that current labeling is insufficient to ensure all potential users minimize the time the balloon remains in vasculature. If left in too long it could lead to embolization.
Dec 7, 2018	Z-0576-2020	—	terminated	The incorrect outer carton box was used for the product.
Aug 7, 2017	Z-3106-2017	—	terminated	Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
Jun 6, 2017	Z-2863-2017	—	terminated	Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.
Oct 31, 2016	Z-0663-2017	—	terminated	Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Oct 31, 2016	Z-0662-2017	—	terminated	Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Oct 31, 2016	Z-0661-2017	—	terminated	Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.
Jan 15, 2016	Z-0758-2016	—	terminated	The product is labeled with an expiration date that is past its shelf life.
Mar 13, 2012	Z-1395-2012	—	terminated	Isolated lots of the 12Fr SLS II Laser Sheath can have a split in the outer jacket.
Jul 18, 2011	Z-2952-2011	—	terminated	Packaging integrity may be compromised, thus sterility can not be assured.
Jul 18, 2011	Z-2951-2011	—	terminated	Packaging integrity may be compromised, thus sterility can not be assured.
Jul 1, 2010	Z-2190-2010	—	terminated	Guidewire lumen may be occluded, preventing guidewire insertion into the catheter.
Mar 16, 2009	Z-1264-2009	—	terminated	Catheter outer jacket may split during use.
Oct 15, 2008	Z-0903-2009	—	terminated	Catheter pouch was mislabeled with the wrong size.
Jul 4, 2008	Z-0976-2009	—	terminated	The catheter pouch label was incorrectly labeled with the wrong size.
Dec 10, 2007	Z-0698-2008	—	terminated	Mislabeling: Catheters were placed into mis-labeled inner pouches as REF Number 518-037, 135 cm--the exterior box labeling is correct as 90 cm.