Cleared Traditional

K223766 - NUVISION™ NAV Ultrasound Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223766 · Biosense Webster, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2023
Decision
63d
Days
Class 2
Risk

K223766 is an FDA 510(k) clearance for the NUVISION™ NAV Ultrasound Catheter. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Biosense Webster, Inc. (Irvine, US). The FDA issued a Cleared decision on February 16, 2023 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biosense Webster, Inc. devices

Submission Details

510(k) Number K223766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - OBJ Catheter, Ultrasound, Intravascular

All 77
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