K912564 is an FDA 510(k) clearance for the MEGA PERICARDIOCENTESIS KIT. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Mega Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on September 5, 1991, 86 days after receiving the submission on June 11, 1991.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K912564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 1991 |
| Decision Date | September 05, 1991 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |