The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Eagle Eye Platinum Rx Digital Ivus Catheter.
| Device ID | K210655 |
| 510k Number | K210655 |
| Device Name: | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Contact | Rick Ferreira |
| Correspondent | Christina Fleming Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Product Code | OWQ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-04 |
| Decision Date | 2022-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898134418 | K210655 | 000 |