The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Reflexion Spiral Bi-directional Variable Radius Electrophysiology Catheter.
| Device ID | K191170 |
| 510k Number | K191170 |
| Device Name: | Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| 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 | NLH |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-01 |
| Decision Date | 2019-10-30 |
| Summary: | summary |