The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Polaris X Steerable Diagnostic Ep Catheter.
| Device ID | K160303 |
| 510k Number | K160303 |
| Device Name: | Reprocessed Polaris X Steerable Diagnostic EP Catheter |
| Classification | Catheter, Recording, Electrode, Reprocessed |
| Applicant | Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Contact | Rafal Chudzik |
| Correspondent | Rafal Chudzik 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 | 2016-02-04 |
| Decision Date | 2016-05-10 |
| Summary: | summary |