The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for 9.5 French Percutaneous Double Lumen Balloon.
| Device ID | K882508 |
| 510k Number | K882508 |
| Device Name: | 9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | David Cromwick |
| Correspondent | David Cromwick 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 | 1988-06-17 |
| Decision Date | 1989-03-20 |