The following data is part of a premarket notification filed by Baxano, Inc. with the FDA for Io-flex Catheter.
| Device ID | K102594 |
| 510k Number | K102594 |
| Device Name: | IO-FLEX CATHETER |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | BAXANO, INC. 655 RIVER OAKS PKWY San Jose, CA 95134 |
| Contact | Edward J Sinclair |
| Correspondent | Edward J Sinclair BAXANO, INC. 655 RIVER OAKS PKWY San Jose, CA 95134 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-09 |
| Decision Date | 2011-01-19 |
| Summary: | summary |