The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Baylis Medical Rf Septostomy Generator, Nykanen Rf Septostomy Catheter, Baylis Medical Connector Cable.
| Device ID | K990284 |
| 510k Number | K990284 |
| Device Name: | BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE |
| Classification | Catheter, Septostomy |
| Applicant | BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 5 Mississauga, CA L4w-4t7 |
| Contact | Kris Shah |
| Correspondent | Kris Shah BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 5 Mississauga, CA L4w-4t7 |
| Product Code | DXF |
| CFR Regulation Number | 870.5175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-29 |
| Decision Date | 2001-02-01 |