The following data is part of a premarket notification filed by Mega Medical, Inc. with the FDA for Mega Pericardiocentesis Kit.
| Device ID | K912564 |
| 510k Number | K912564 |
| Device Name: | MEGA PERICARDIOCENTESIS KIT |
| Classification | Catheter, Percutaneous |
| Applicant | MEGA MEDICAL, INC. P.O. BOX 260956 Tampa, FL 33685 |
| Contact | Ellen Joy |
| Correspondent | Ellen Joy MEGA MEDICAL, INC. P.O. BOX 260956 Tampa, FL 33685 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-11 |
| Decision Date | 1991-09-05 |