K093307 is an FDA 510(k) clearance for the ASEPT PLEURAL DRAINAGE SYSTEM. This device is classified as a Apparatus, Suction, Patient Care (Class II - Special Controls, product code DWM).
Submitted by Pfm Medical, Inc. (Oceanside, US). The FDA issued a Cleared decision on November 6, 2009, 15 days after receiving the submission on October 22, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.5050.
| 510(k) Number | K093307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 2009 |
| Decision Date | November 06, 2009 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | DWM — Apparatus, Suction, Patient Care |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5050 |