Access Vascular, Inc
Billerica, MA, US
ACCESS VASCULAR, INC appears in FDA device records in Billerica, MA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Access Vascular, Inc between 2018 and 2025. The busiest year on record is 2025, with 4. The most recent is 2025, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 2 |
| 2025 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | LJS | Substantially Equivalent | |
| 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 | |
| K243941 | 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) | LJS | Substantially Equivalent | |
| K220772 | HydroMID 4F Single Lumen Midline Catheter | FOZ | Substantially Equivalent | |
| K213550 | HydroPICC 5F Dual Lumen Catheter | LJS | Substantially Equivalent | |
| K203069 | HydroMID | FOZ | Substantially Equivalent | |
| K193015 | HydroPICC (PICC-142) | LJS | Substantially Equivalent | |
| K172885 | HydroPICC | LJS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3021570645 | 3021570645 | ACCESS VASCULAR, INC | 749 Middlesex Turnpike, Billerica, MA 01821 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0115-2024 | HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004 | 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. | Class II | Open, Classified | |
| Z-0114-2024 | 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 been no reported adverse events to date. | Class II | Open, Classified | |
| Z-1605-2023 | 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. | Class II | Open, Classified | |
| Z-1156-2023 | 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 | Class II | Open, Classified | |
| Z-1155-2023 | 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 | Class II | Open, Classified | |
| Z-1131-2023 | HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001 | 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. | Class II | Open, Classified | |
| Z-1130-2023 | HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002 | 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. | Class II | Open, Classified | |
| Z-1129-2023 | 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. | Class II | Open, Classified | |
| Z-0199-2023 | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain