K993062 is an FDA 510(k) clearance for the CHEST DRAINAGE TUBING. This device is classified as a Tubing, Pump, Cardiopulmonary Bypass (Class II - Special Controls, product code DWE).
Submitted by Olson Medical Sales, Inc. (Somerset, US). The FDA issued a Cleared decision on December 10, 1999, 88 days after receiving the submission on September 13, 1999.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4390.
| 510(k) Number | K993062 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 1999 |
| Decision Date | December 10, 1999 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWE — Tubing, Pump, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4390 |