Cleared Traditional

K932092 - USCI ANGIOGRAPHIC CATHETER (FDA 510(k) Clearance)

Jul 1993
Decision
90d
Days
Class 2
Risk

K932092 is an FDA 510(k) clearance for the USCI ANGIOGRAPHIC CATHETER. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on July 29, 1993, 90 days after receiving the submission on April 30, 1993.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.

Submission Details

510(k) Number K932092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1993
Decision Date July 29, 1993
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQO — Catheter, Intravascular, Diagnostic
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.1200