K243458
- 510(k) number
- K243458
- Device name
- 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. MA · US
- Product code
- LJS — Catheter, Intravascular, Therapeutic, Long-Term Grea
- Decision date
- 2025-08-01
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K243458.pdf
Official FDA record: K243458
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.