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 |