The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Supreme Diagnostic Electrophysiology Catheters.
| Device ID | K161769 |
| 510k Number | K161769 |
| Device Name: | Reprocessed Supreme Diagnostic Electrophysiology Catheters |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | INNOVATIVE HEALTH, LLC. 1435 NORTH HAYDEN ROAD SUITE 100 Scottsdale, AZ 85257 |
| Contact | Sharon Higgins |
| Correspondent | Rafal Chudzik 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 | 2016-06-28 |
| Decision Date | 2016-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898114922 | K161769 | 000 |
| 10841898114281 | K161769 | 000 |
| 10841898114236 | K161769 | 000 |
| 10841898113857 | K161769 | 000 |
| 10841898114946 | K161769 | 000 |
| 10841898114885 | K161769 | 000 |
| 10841898114458 | K161769 | 000 |
| 10841898114403 | K161769 | 000 |
| 10841898114274 | K161769 | 000 |
| 10841898114243 | K161769 | 000 |
| 10841898114427 | K161769 | 000 |
| 10841898114472 | K161769 | 000 |
| 10841898114489 | K161769 | 000 |
| 10841898114915 | K161769 | 000 |
| 10841898114892 | K161769 | 000 |
| 10841898114878 | K161769 | 000 |
| 10841898114359 | K161769 | 000 |
| 10841898113918 | K161769 | 000 |
| 10841898113864 | K161769 | 000 |
| 10841898114953 | K161769 | 000 |
| 10841898114908 | K161769 | 000 |
| 10841898114854 | K161769 | 000 |
| 10841898114212 | K161769 | 000 |