Cleared Special

FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER

K130507 · Footprint Medical, Inc. · General Hospital
Jun 2013
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K130507 is an FDA 510(k) clearance for the FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Footprint Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on June 3, 2013, 96 days after receiving the submission on February 27, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K130507 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2013
Decision Date June 03, 2013
Days to Decision 96 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement

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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