Cleared Traditional

K231044 - R2P Navicross

K231044 is an FDA 510(k) clearance for R2P Navicross, manufactured by Terumo Medical Corporation. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K231044 · Terumo Medical Corporation · Cardiovascular device
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Jul 2023
Decision
106d
Days
Class 2
Risk

K231044 is an FDA 510(k) clearance for the R2P Navicross. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Terumo Medical Corporation (Elkton, US). The FDA issued a Cleared decision on July 27, 2023 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Terumo Medical Corporation devices

FDA 510(k) Submission Details - K231044

510(k) Number K231044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2023
Decision Date July 27, 2023
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K231044.
Ventrax™ Delivery System (VTR851)
K231246 · Merit Medical Systems, Inc. · Aug 2023
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
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Rubicon™ Control Support Catheter (H749394323506A1)
K223633 · Boston Scientific Corporation · Aug 2023
Micro Rx
K223728 · Imds Operations B.V. · Jul 2023
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
K230156 · Medtronic Vascular · Jun 2023
CPS Direct™ Universal slittable outer guide catheter (DS2C029)
K231311 · Abbott Medical · Jun 2023