K870784 is an FDA 510(k) clearance for the A.T.S. 1500 TOURNIQUET. This device is classified as a Tourniquet, Pneumatic (Class I - General Controls, product code KCY).
Submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on March 18, 1987, 20 days after receiving the submission on February 26, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5910.
| 510(k) Number | K870784 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 1987 |
| Decision Date | March 18, 1987 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KCY — Tourniquet, Pneumatic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.5910 |