K173262 is an FDA 510(k) clearance for the Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter. This device is classified as a Reprocessed Intravascular Ultrasound Catheter (Class II - Special Controls, product code OWQ).
Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on March 6, 2018, 146 days after receiving the submission on October 11, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200. For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology..
| 510(k) Number | K173262 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 11, 2017 |
| Decision Date | March 06, 2018 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | OWQ — Reprocessed Intravascular Ultrasound Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
| Definition | For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology. |