K050411 is an FDA 510(k) clearance for the ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM. This device is classified as a Tourniquet, Pneumatic (Class I - General Controls, product code KCY).
Submitted by Zimmer, Inc. (Dover, US). The FDA issued a Cleared decision on September 2, 2005, 197 days after receiving the submission on February 17, 2005.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5910.
| 510(k) Number | K050411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2005 |
| Decision Date | September 02, 2005 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KCY — Tourniquet, Pneumatic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.5910 |