Cleared Traditional

PRO-PICC WITH VALVE TECHNOLOGY

K141633 · Medical Components, Inc. · General Hospital
Sep 2014
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K141633 is an FDA 510(k) clearance for the PRO-PICC WITH VALVE TECHNOLOGY, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on September 29, 2014, 103 days after receiving the submission on June 18, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K141633 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2014
Decision Date September 29, 2014
Days to Decision 103 days
Submission Type Traditional
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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