Cleared Traditional

INSITUCAT VALVE STRIPPER

K885046 · Aesculap Instruments Corp. · Cardiovascular
Feb 1990
Decision
450d
Days
Class 2
Risk

About This 510(k) Submission

K885046 is an FDA 510(k) clearance for the INSITUCAT VALVE STRIPPER, a Stripper, Vein, External (Class II — Special Controls, product code DWQ), submitted by Aesculap Instruments Corp. (Burlingame, US). The FDA issued a Cleared decision on February 28, 1990, 450 days after receiving the submission on December 5, 1988. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K885046 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 1988
Decision Date February 28, 1990
Days to Decision 450 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DWQ — Stripper, Vein, External
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4885