The following data is part of a premarket notification filed by Innovative Health, Llc with the FDA for Reprocessed Visions Pv .035 Digital Ivus Catheter.
| Device ID | K181126 |
| 510k Number | K181126 |
| Device Name: | Reprocessed Visions PV .035 Digital IVUS Catheter |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | Innovative Health, LLC 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 |
| Contact | Amanda Babcock |
| Correspondent | Amanda Babcock 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 | 2018-04-30 |
| Decision Date | 2019-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B227R889010 | K181126 | 000 |
| B227RS889011 | K181126 | 000 |