K852041 is an FDA 510(k) clearance for the DEKNATEL THORACIC CATHETER. This device is classified as a Catheter And Tip, Suction (Class II - Special Controls, product code JOL).
Submitted by Pfizer, Inc. (Ny, US). The FDA issued a Cleared decision on June 17, 1985, 39 days after receiving the submission on May 9, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K852041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 1985 |
| Decision Date | June 17, 1985 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | JOL — Catheter And Tip, Suction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |