Cleared Traditional

GLIDECROSS SUPPORT CATHETER

K111556 · Terumo Medical Corp. · Cardiovascular
Jul 2011
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K111556 is an FDA 510(k) clearance for the GLIDECROSS SUPPORT CATHETER, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on July 29, 2011, 53 days after receiving the submission on June 6, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K111556 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2011
Decision Date July 29, 2011
Days to Decision 53 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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