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ACCESS VASCULAR, INC

Last updated September 17, 2026

Information

Country: US
Address: 749 Middlesex Turnpike, Billerica, MA, 01821
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3021570645
DUNS Number: —

Catalogue (45)

Device	Model / Reference	Registries	Class	Status
HydroPICC Dual Lumen	80H02104	FDA UDI	Class II	Active
HydroPICC Basic Kit (130cm GW)	80001001	FDA UDI	Class II	Active
HydroMID	90004104	FDA UDI	Class II	Active
HydroPICC Dual Lumen	80H02101	FDA UDI	Class II	Active
HydroPICC Dual Lumen	80002002	FDA UDI	Class II	Active
HydroPICC Full Kit	80001003	FDA UDI	Class II	Active
HydroPICC Catheter	PICC-251CM	FDA UDI	Class II	Active
HydroMID Basic Kit	80H04102	FDA UDI	Class II	Active
HydroPICC	PICC-142S	FDA UDI	Class II	Active
HydroPICC Basic Kit (70cm GW)	80H01102	FDA UDI	Class II	Active
HydroPICC Catheter	PICC-142CM	FDA UDI	Class II	Active
HydroMID Basic Kit	80004102	FDA UDI	Class II	Active
HydroPICC Maximal Barrier Kit	80001004	FDA UDI	Class II	Active
HydroMID Full Kit	80004003	FDA UDI	Class II	Active
HydroPICC Dual Lumen	80H02102	FDA UDI	Class II	Active
HydroPICC Dual Lumen	80002102	FDA UDI	Class II	Active
HydroPICC	90001104	FDA UDI	Class II	Active
HydroPICC Dual Lumen	80002104	FDA UDI	Class II	Active
HydroPICC Basic Kit (80cm GW)	80001002	FDA UDI	Class II	Active
HydroMID Maximal Barrier Kit	80H04104	FDA UDI	Class II	Active
HydroMID Basic Kit	80004002	FDA UDI	Class II	Active
HydroPICC Dual Lumen	80002001	FDA UDI	Class II	Active
HydroMID Catheter	MID-141CM	FDA UDI	Class II	Active
HydroPICC Basic Kit (130cm GW)	80H01101	FDA UDI	Class II	Active
HydroMID	MID-141	FDA UDI	Class II	Active
HydroPICC	PICC-142	FDA UDI	Class II	Active
HydroPICC Maximal Barrier Kit	80H01104	FDA UDI	Class II	Active
HydroPICC Dual Lumen	90002104	FDA UDI	Class II	Active
HydroPICC Basic Kit (80cm GW)	80001102	FDA UDI	Class II	Active
HydroMID Maximal Barrier Kit	80004104	FDA UDI	Class II	Active
HydroPICC Dual Lumen	80002101	FDA UDI	Class II	Active
HydroPICC Maximal Barrier Kit	80001104	FDA UDI	Class II	Active
HydroPICC	PICC-141	FDA UDI	Class II	Unknown
HydroPICC Dual Lumen	80002004	FDA UDI	Class II	Active
HydroPICC Basic Kit (130cm GW)	80001101	FDA UDI	Class II	Active
HydroMID Maximal Barrier Kit	80004004	FDA UDI	Class II	Active
HydroPICC 5F Dual Lumen Catheter	K213550	FDA 510(k)	Class II	Active
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr	K243458	FDA 510(k)	Class II	Active
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204)	K243941	FDA 510(k)	Class II	Active
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)	K251212	FDA 510(k)	Class II	Active
HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)	K244059	FDA 510(k)	Class II	Active
HydroPICC	K172885	FDA 510(k)	Class II	Active
HydroMID	K203069	FDA 510(k)	Class II	Active
HydroMID 4F Single Lumen Midline Catheter	K220772	FDA 510(k)	Class II	Active
HydroPICC (PICC-142)	K193015	FDA 510(k)	Class II	Active

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FDA Recalls (9)

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 31, 2023	Z-0115-2024	—	open, classified	Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
Aug 31, 2023	Z-0114-2024	—	open, classified	Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
Mar 3, 2023	Z-1605-2023	—	open, classified	The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.
Dec 22, 2022	Z-1156-2023	—	open, classified	Label with the incorrect component listed on the inner kit Tyvek header bag
Dec 22, 2022	Z-1155-2023	—	open, classified	Product Mislabeled on the outer bag and inner kit Tyvek header bag
Dec 16, 2022	Z-1131-2023	—	open, classified	Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Dec 16, 2022	Z-1130-2023	—	open, classified	Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Dec 16, 2022	Z-1129-2023	—	open, classified	Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
Feb 24, 2021	Z-0199-2023	—	terminated	Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.