HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more— 510(k) K243458

Clearance details

Device name as filed

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

Applicant

Access Vascular, Inc.

Product code

Code LJS

Device class

Class 2

Regulation

21 CFR 880.5970

Advisory panel

General Hospital

Date received

2024-11-08

Decision date

2025-08-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Ballerica, MA, US

• K260929 — Neonav ECG Tip Location System2026-04-17
• K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more2025-12-16
• K252792 — PM2 System with ECGuide Connector2025-11-17
• K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)2025-07-01
• K243484 — PM2+ System and SmartPICC Stylet2025-05-29

• K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102) +2 more2025-03-27
• K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201) +3 more2025-01-17
• K220772 — HydroMID 4F Single Lumen Midline Catheter2022-12-07
• K213550 — HydroPICC 5F Dual Lumen Catheter2022-05-04
• K203069 — HydroMID2021-02-08

Death

31

Injury

2,791

Malfunction

18,374

Other

5

Total

21,201

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →