Cleared Traditional

ATS 500 TOURNIQUET

K853802 · Aspen Laboratories, Inc. · General & Plastic Surgery
Oct 1985
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K853802 is an FDA 510(k) clearance for the ATS 500 TOURNIQUET, a Tourniquet, Pneumatic (Class I — General Controls, product code KCY), submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on October 7, 1985, 26 days after receiving the submission on September 11, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5910.

Submission Details

510(k) Number K853802 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 1985
Decision Date October 07, 1985
Days to Decision 26 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KCY — Tourniquet, Pneumatic
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.5910

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