The following data is part of a premarket notification filed by Arrow International Inc. with the FDA for Arrow Fiberoptix Intra-aortic Balloon Catheter Kit.
| Device ID | K200634 |
| 510k Number | K200634 |
| Device Name: | Arrow FiberOptix Intra-Aortic Balloon Catheter Kit |
| Classification | System, Balloon, Intra-aortic And Control |
| Applicant | Arrow International Inc. 16 Elizabeth Drive Chelmsford, MA 01824 |
| Contact | Apurva N. Gokhale |
| Correspondent | Apurva N. Gokhale Arrow International Inc. 16 Elizabeth Drive Chelmsford, MA 01824 |
| Product Code | DSP |
| CFR Regulation Number | 870.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-10 |
| Decision Date | 2020-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10801902216806 | K200634 | 000 |
| 10801902216783 | K200634 | 000 |
| 10801902216349 | K200634 | 000 |