K910693 is an FDA 510(k) clearance for the PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET. This device is classified as a Catheter And Tip, Suction (Class II - Special Controls, product code JOL).
Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on October 17, 1991, 240 days after receiving the submission on February 19, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K910693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 1991 |
| Decision Date | October 17, 1991 |
| Days to Decision | 240 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 |