The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for 9.5 Fr Percutaneous Db Lumen 40cc Flexi-cath (tm).
Device ID | K903344 |
510k Number | K903344 |
Device Name: | 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) |
Classification | System, Balloon, Intra-aortic And Control |
Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
Contact | Cesidio Tempesta |
Correspondent | Cesidio Tempesta KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
Product Code | DSP |
CFR Regulation Number | 870.3535 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-25 |
Decision Date | 1991-01-15 |