Submission Details
| 510(k) Number | K190478 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 27, 2019 |
| Decision Date | November 14, 2019 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Reprocessed ViewFlex? Xtra ICE Catheter
Nov 2019
Decision
260d
Days
Class 2
Risk
About This 510(k) Submission
K190478 is an FDA 510(k) clearance for the Reprocessed ViewFlex? Xtra ICE Catheter, a Reprocessed Intravascular Ultrasound Catheter (Class II — Special Controls, product code OWQ), submitted by Sterilmed, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 14, 2019, 260 days after receiving the submission on February 27, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.
Device Classification
| 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. |
Manufacturer
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