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)

510(k) number: K243941
Device name: 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)
Applicant: Access Vascular, Inc. MA · US
Product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Grea
Decision date: 2025-01-17
Date received: 2024-12-20
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: General Hospital

PDFDownload 510(k) SummaryArchived here · 2.3 MB · U.S. public domain

Also available from FDA: K243941.pdf

Official FDA record: K243941

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.