Cleared Traditional

CORDIS PTCA GUIDING CATHETER, MODIFICATION

K913783 · Dow Corning Wright · Cardiovascular
Oct 1991
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K913783 is an FDA 510(k) clearance for the CORDIS PTCA GUIDING CATHETER, MODIFICATION, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on October 18, 1991, 65 days after receiving the submission on August 14, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K913783 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1991
Decision Date October 18, 1991
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

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

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