Cleared Traditional

K213492 - Dib UltraNav Transseptal Catheter System

K213492 is an FDA 510(k) clearance for Dib UltraNav Transseptal Catheter System, manufactured by Dib Ultranav Medical, LLC. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K213492 · Dib Ultranav Medical, LLC · Cardiovascular device
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Mar 2022
Decision
143d
Days
Class 2
Risk

K213492 is an FDA 510(k) clearance for the Dib UltraNav Transseptal Catheter System. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Dib Ultranav Medical, LLC (El Paso, US). The FDA issued a Cleared decision on March 24, 2022 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Dib Ultranav Medical, LLC devices

FDA 510(k) Submission Details - K213492

510(k) Number K213492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2021
Decision Date March 24, 2022
Days to Decision 143 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
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 Consultant

The Tamarack Group – Mpls, LLC
Noelle Sutton

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DYB Introducer, Catheter

All 438
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K213492.
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