Home / Companies / Access Vascular, Inc.

Access Vascular, Inc.

FDA Regulatory Profile

Summary

Total Recalls
9
510(k) Clearances
9
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0114-2024Class IIHydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002August 31, 2023
Z-0115-2024Class IIHydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004August 31, 2023
Z-1605-2023Class IIHydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004March 3, 2023
Z-1155-2023Class IIHydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peDecember 22, 2022
Z-1156-2023Class IIHydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the perDecember 22, 2022
Z-1129-2023Class IIHydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002December 16, 2022
Z-1131-2023Class IIHydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001December 16, 2022
Z-1130-2023Class IIHydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002December 16, 2022
Z-0199-2023Class IIScalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central February 24, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr SAugust 1, 2025
K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICJuly 1, 2025
K244059HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline CatheMarch 27, 2025
K243941HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr January 17, 2025
K220772HydroMID 4F Single Lumen Midline CatheterDecember 7, 2022
K213550HydroPICC 5F Dual Lumen CatheterMay 4, 2022
K203069HydroMIDFebruary 8, 2021
K193015HydroPICC (PICC-142)February 20, 2020
K172885HydroPICCFebruary 20, 2018