Cleared Special

Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)

K251212 · Access Vascular, Inc. · General Hospital
Jul 2025
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K251212 is an FDA 510(k) clearance for the Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM), a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Access Vascular, Inc. (Ballerica, US). The FDA issued a Cleared decision on July 1, 2025, 74 days after receiving the submission on April 18, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K251212 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2025
Decision Date July 01, 2025
Days to Decision 74 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

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