The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Advisor Fl Circular Mapping Catheter, Sensor Enabled.
| Device ID | K200205 |
| 510k Number | K200205 |
| Device Name: | Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | Stryker Sustainability Solutions 1810 W Drake Drive Tempe, AZ 85283 |
| Contact | Mia Mccorkel |
| Correspondent | Mia Mccorkel Stryker Sustainability Solutions 1810 W Drake Drive Tempe, AZ 85283 |
| Product Code | NLH |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-28 |
| Decision Date | 2020-05-13 |