The following data is part of a premarket notification filed by Cardio Medical Solutions, Inc. with the FDA for Baladi Inverter With Coaxial Aortic Punch.
| Device ID | K980128 |
| 510k Number | K980128 |
| Device Name: | BALADI INVERTER WITH COAXIAL AORTIC PUNCH |
| Classification | Clamp, Vascular |
| Applicant | CARDIO MEDICAL SOLUTIONS, INC. 17080 NEWHOPE ST. Fountain Valley, CA 92708 |
| Contact | Thomas P Schroeder |
| Correspondent | Thomas P Schroeder CARDIO MEDICAL SOLUTIONS, INC. 17080 NEWHOPE ST. Fountain Valley, CA 92708 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-14 |
| Decision Date | 1998-07-24 |
| Summary: | summary |