Submission Details
| 510(k) Number | K223766 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 15, 2022 |
| Decision Date | February 16, 2023 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
NUVISION? NAV Ultrasound Catheter
Feb 2023
Decision
63d
Days
Class 2
Risk
About This 510(k) Submission
K223766 is an FDA 510(k) clearance for the NUVISION? NAV Ultrasound Catheter, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on February 16, 2023, 63 days after receiving the submission on December 15, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.
Device Classification
| Product Code | OBJ — Catheter, Ultrasound, Intravascular |
| 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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