The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Intra-aortic Balloon Pump Catheter - Modification.
| Device ID | K923603 |
| 510k Number | K923603 |
| Device Name: | INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION |
| Classification | Introducer, Catheter |
| Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | Wayne P Grifgin |
| Correspondent | Wayne P Grifgin KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-02 |
| Decision Date | 1993-03-08 |