The following data is part of a premarket notification filed by Baylis Medical Company Inc. with the FDA for Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable.
| Device ID | K183632 |
| 510k Number | K183632 |
| Device Name: | Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | Baylis Medical Company Inc. 2580 Matheson Blvd. E Mississauga, CA L4w 4j1 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar Baylis Medical Company Inc. 2580 Matheson Blvd. E Mississauga, CA L4w 4j1 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-26 |
| Decision Date | 2019-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447003755 | K183632 | 000 |
| 00685447003731 | K183632 | 000 |
| 00685447003724 | K183632 | 000 |