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IMPERATIVE CARE INC.

Last updated September 17, 2026

Information

Country: US
Address: 1359 Dell Ave, Campbell, CA, 95008
Website: —
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Email: —
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PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3014590708
DUNS Number: —

Catalogue (87)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Zoom RDL Radial Access System, 105cm	ICTC088105R	FDA UDI	Class II	Active
Zoom 88 Large Distal Platform	ICTC088110	FDA UDI	Class II	Active
Prodigy™ Catheter	PRODIGY5F	FDA UDI	Class II	Active
TracStar™ Large Distal Platform	ICAC088095	FDA UDI	Class II	Unknown
ZOOM™ Reperfusion Catheter	ICRC035158	FDA UDI	Class II	Active
Zoom 6F Insert Catheter, VRT	IC6FVRT137	FDA UDI	Class II	Active
Prodigy Twist™	TWIST8F-S	FDA UDI	Class II	Unknown
Symphony™ Advance™ Long Dilator	ADVANCE	FDA UDI	Class II	Active
TracStar™ Large Distal Platform	ICAC088080	FDA UDI	Class II	Unknown
ZOOM™ 88-T Large Distal Platform	ICTC088100	FDA UDI	Class II	Active
Hotshot™ Controller	HOTSHOT	FDA UDI	Class II	Active
Symphony™ ProHelix™	PROHELIX24F	FDA UDI	Class II	Active
ZOOM™ 88-T Large Distal Platform	ICTC088110	FDA UDI	Class II	Active
ZOOM™ Reperfusion Catheter	ICRC035158	FDA UDI	Class II	Unknown
Symphony™ Catheter	SYMPHONY24F	FDA UDI	Class II	Active
ZOOM™ Reperfusion Catheter	ICRC071137	FDA UDI	Class II	Active
TRX™ Long Sheath	ICAC088090	FDA UDI	Class II	Unknown
ZOOM™ 88-T Large Distal Platform	ICTC088110	FDA UDI	Class II	Active
Prodigy™ Catheter	PRODIGY8F-S	FDA UDI	Class II	Unknown
Prodigy Twist™	TWIST5F	FDA UDI	Class II	Active
X-Wire Guidewire	K244061	FDA 510(k)	Class II	Active
ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing	K211476	FDA 510(k)	Class II	Active
Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System	K252057	FDA 510(k)	Class II	Active
Zoom System	K242672	FDA 510(k)	Class II	Active
Zoom System (Zoom 4S Catheter)	K252046	FDA 510(k)	Class II	Active
TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform	K203764	FDA 510(k)	Class II	Active
Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System	K250775	FDA 510(k)	Class II	Active
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support	K240948	FDA 510(k)	Class II	Active
EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length	K180169	FDA 510(k)	Class II	Active
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing	K202182	FDA 510(k)	Class II	Active
Zoom 6F Insert Catheters	K233975	FDA 510(k)	Class II	Active
Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing	K243047	FDA 510(k)	Class II	Active
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support	K231168	FDA 510(k)	Class II	Active
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform	K212224	FDA 510(k)	Class II	Active
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing	K210996	FDA 510(k)	Class II	Active
Imperative Care Radial 088 Access System	K220807	FDA 510(k)	Class II	Active
0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter	K183043	FDA 510(k)	Class II	Active

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FDA Recalls (1)

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
Aug 13, 2021	Z-2577-2021	—	completed	There is a potential for distal end of catheters to fracture and become detached.