Cleared Traditional

BURKE CONGENITAL THORACOSCOPY INSTRUMENTS

K962771 · Pilling Weck, Inc. · Cardiovascular
Nov 1996
Decision
126d
Days
Class 1
Risk

About This 510(k) Submission

K962771 is an FDA 510(k) clearance for the BURKE CONGENITAL THORACOSCOPY INSTRUMENTS, a Instruments, Surgical, Cardiovascular (Class I — General Controls, product code DWS), submitted by Pilling Weck, Inc. (Fort Washington, US). The FDA issued a Cleared decision on November 19, 1996, 126 days after receiving the submission on July 16, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4500.

Submission Details

510(k) Number K962771 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 1996
Decision Date November 19, 1996
Days to Decision 126 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWS — Instruments, Surgical, Cardiovascular
Device Class Class I — General Controls
CFR Regulation 21 CFR 870.4500

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