The following data is part of a premarket notification filed by Innovative Health, Llc with the FDA for Reprocessed Livewire Steerable Diagnostic Ep Catheter.
| Device ID | K160242 |
| 510k Number | K160242 |
| Device Name: | Reprocessed Livewire 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 | 2016-02-01 |
| Decision Date | 2016-05-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898123108 | K160242 | 000 |
| 10841898111587 | K160242 | 000 |
| 10841898111594 | K160242 | 000 |
| 10841898111600 | K160242 | 000 |
| 10841898111617 | K160242 | 000 |
| 10841898111624 | K160242 | 000 |
| 10841898111778 | K160242 | 000 |
| 10841898111563 | K160242 | 000 |
| 10841898111655 | K160242 | 000 |
| 10841898111761 | K160242 | 000 |
| 10841898111570 | K160242 | 000 |