The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Novemperc Double Lumen Intra-aortic Balloon.
| Device ID | K860638 |
| 510k Number | K860638 |
| Device Name: | NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | George Cho |
| Correspondent | George Cho 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 | 1986-02-20 |
| Decision Date | 1986-10-01 |