ACCESS VASCULAR, INC

FDA Device Registration & Listing · Billerica, MA, US · Registration 3021570645

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021570645
FEI Number
3021570645
Entity Name
ACCESS VASCULAR, INC
City/State/Country
Billerica, MA, US
Establishment Address
749 Middlesex Turnpike, Billerica, MA 01821, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Access Vascular, Inc (Owner Number: 10058643)
Owner / Operator Contact Address
749 Middlesex Turnpike, Billerica, MA 01821, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K244059
PMA Number
N/A

All Registered Proprietary Names

HydroMID MID-251

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2026-06-09

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Access Vascular, Inc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K943349 Quinton, Inc. MAHURKAR DUAL LUMEN CATHETER 1995-03-22
K912158 Medical Device Inspection Co., Inc. CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY 1991-10-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2024 ARROW INTERNATIONAL Inc. 2
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024 ARROW INTERNATIONAL Inc. 2
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023 B Braun Medical Inc 2
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024 Becton Dickinson Infusion Therapy Systems Inc. 2
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021570645. Last updated year: 2026. Please use registration number 3021570645 when referencing this establishment in official correspondence.
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