The following data is part of a premarket notification filed by Innovative Health, Llc. with the FDA for Reprocessed Viewflex Xtra Ice Diagnostic Ultrasound Catheter.
| Device ID | K173262 |
| 510k Number | K173262 |
| Device Name: | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter |
| Classification | Reprocessed Intravascular Ultrasound Catheter |
| Applicant | Innovative Health, Llc. 1435 North Hayden Road Suite 100 Scottsdale, AZ 85257 |
| Contact | Amy Stoklas-oakes |
| Correspondent | Amy Stoklas-oakes 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 | 2017-10-11 |
| Decision Date | 2018-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841898123252 | K173262 | 000 |