The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Toronto Rf Septostomy Catheter, Model Tsc-50-75.
| Device ID | K031949 |
| 510k Number | K031949 |
| Device Name: | TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75 |
| Classification | Catheter, Septostomy |
| Applicant | BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 33 Mississauga, Ontario, CA L4w-4t7 |
| Contact | Amanda Hartley |
| Correspondent | Amanda Hartley BAYLIS MEDICAL CO., INC. 5160 EXPLORER DRIVE, UNIT 33 Mississauga, Ontario, 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 | 2003-06-24 |
| Decision Date | 2003-12-10 |