The following data is part of a premarket notification filed by Abbott Medical with the FDA for Advisor Vl Circular Mapping Catheter, Sensor Enabled.
| Device ID | K192037 |
| 510k Number | K192037 |
| Device Name: | Advisor VL Circular Mapping Catheter, Sensor Enabled |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | Abbott Medical 5050 Nathan Lane North Plymouth, MN 55442 |
| Contact | Tamara L. Stanczak |
| Correspondent | Tamara L. Stanczak Abbott Medical 5050 Nathan Lane North Plymouth, MN 55442 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-30 |
| Decision Date | 2019-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067027283 | K192037 | 000 |
| 05415067027276 | K192037 | 000 |
| 05415067027269 | K192037 | 000 |
| 05415067027252 | K192037 | 000 |