The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Supreme Diagnostic Electrophysiology Catheter.
| Device ID | K182386 |
| 510k Number | K182386 |
| Device Name: | Reprocessed Supreme Diagnostic Electrophysiology Catheter |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Contact | Amanda Babcock |
| Correspondent | Amanda Babcock Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-04 |
| Decision Date | 2019-04-23 |