510(k) K202919 ยท KCY Tourniquet, Pneumatic
ATS 5000 Automatic Tourniquet Instrument
| Applicant | Mcewen and Associates Consulting , Ltd., Vancouver, CA |
| Decision | Substantially Equivalent, May 20, 2021 |
| Received | Sep 29, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2026 | Zimmer Surgical Inc Brand Name: Zimmer Tourniquet Systems
Product Name: A.T.S. 5000TS Tourniquet Systems
Model/Catalog Number: 60500010100
Software Version: Software version v2.04 or prior are within scope of the recall Open, Classified |
KCY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.