Data / Medical devices / United States / Access Vascular, Inc
Access Vascular, Inc: FDA-registered device maker in Billerica, MA, United States, 2 510(k) clearances
Access Vascular, Inc is registered with the FDA (registration 3021570645) in Billerica, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 1, 2025. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021570645
- Address
- 749 Middlesex Turnpike, Billerica, MA, United States, 01821
- Owner or operator
- Access Vascular, Inc (10058643)
- Roles
- Manufacturer
- First device listed
- June 9, 2026
- Registered through
- 2026
- Brand names listed
- HydroMID, HydroPICC, MID-141, MID-251, PICC-142, PICC-251, PICC-252
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | 2 | Manufacturer | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 1, 2025 | K243458 | 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 | LJS | Substantially Equivalent | Access Vascular, Inc. | accessdata.fda.gov |
| March 27, 2025 | K244059 | 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) | FOZ | Substantially Equivalent | Access Vascular, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 31, 2023 | 93043 | Class II | Ongoing | HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002 | 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 | accessdata.fda.gov |
| March 3, 2023 | 92124 | Class II | Ongoing | HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004 | 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. | accessdata.fda.gov |
| December 22, 2022 | 91533 | Class II | Ongoing | HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004 | Label with the incorrect component listed on the inner kit Tyvek header bag | accessdata.fda.gov |
| December 22, 2022 | 91529 | Class II | Ongoing | HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004 | Product Mislabeled on the outer bag and inner kit Tyvek header bag | accessdata.fda.gov |
| December 16, 2022 | 91426 | Class II | Ongoing | HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 | 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. | accessdata.fda.gov |
| February 24, 2021 | 90981 | Class II | Terminated | Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Updated August 1, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.