K910963 is an FDA 510(k) clearance for the THOROCENTESIS KIT. This device is classified as a Catheter And Tip, Suction (Class II - Special Controls, product code JOL).
Submitted by Megadyne Medical Products, Inc. (Hauppauge, US). The FDA issued a Cleared decision on June 20, 1991, 106 days after receiving the submission on March 6, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K910963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - De Novo Granted (SEKD) |
| Date Received | March 06, 1991 |
| Decision Date | June 20, 1991 |
| Days to Decision | 106 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 |