The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Advisor Hd Grid Mapping Catheter, Sensor Enabled.
| Device ID | K200212 |
| 510k Number | K200212 |
| Device Name: | Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled |
| Classification | Catheter, Intracardiac Mapping, High-density Array |
| Applicant | Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Contact | Rick Ferreira |
| Correspondent | Amanda Babcock Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Product Code | MTD |
| 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 | 2020-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898130731 | K200212 | 000 |