K000830 is an FDA 510(k) clearance for the CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE. This device is classified as a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II - Special Controls, product code DWF).
Submitted by California Medical Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on September 7, 2000, 177 days after receiving the submission on March 14, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4210.
| 510(k) Number | K000830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 2000 |
| Decision Date | September 07, 2000 |
| Days to Decision | 177 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4210 |