Cleared Traditional

JMS SAFE WING CATH (SWC)

K121488 · JMS North America Corporation · General Hospital
Mar 2013
Decision
291d
Days
Class 2
Risk

About This 510(k) Submission

K121488 is an FDA 510(k) clearance for the JMS SAFE WING CATH (SWC), a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by JMS North America Corporation (Crofton, US). The FDA issued a Cleared decision on March 5, 2013, 291 days after receiving the submission on May 18, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K121488 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2012
Decision Date March 05, 2013
Days to Decision 291 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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