The following data is part of a premarket notification filed by Innovative Health, Llc with the FDA for Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters.
| Device ID | K161464 |
| 510k Number | K161464 |
| Device Name: | Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters |
| 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 | 2016-05-26 |
| Decision Date | 2016-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898121395 | K161464 | 000 |
| 10841898113406 | K161464 | 000 |
| 10841898113390 | K161464 | 000 |
| 10841898113383 | K161464 | 000 |
| 10841898113376 | K161464 | 000 |
| 10841898113369 | K161464 | 000 |
| 10841898117251 | K161464 | 000 |
| 10841898117282 | K161464 | 000 |
| 10841898117275 | K161464 | 000 |
| 10841898117244 | K161464 | 000 |
| 10841898117152 | K161464 | 000 |
| 10841898117145 | K161464 | 000 |
| 10841898117138 | K161464 | 000 |
| 10841898117169 | K161464 | 000 |
| 10841898117176 | K161464 | 000 |
| 10841898117183 | K161464 | 000 |
| 10841898121333 | K161464 | 000 |
| 10841898117237 | K161464 | 000 |
| 10841898117220 | K161464 | 000 |
| 10841898117206 | K161464 | 000 |
| 10841898117190 | K161464 | 000 |
| 10841898121388 | K161464 | 000 |
| 10841898121371 | K161464 | 000 |
| 10841898121364 | K161464 | 000 |
| 10841898121357 | K161464 | 000 |
| 10841898117299 | K161464 | 000 |
| 10841898117268 | K161464 | 000 |
| 10841898117213 | K161464 | 000 |
| 10841898117121 | K161464 | 000 |