Cleared Traditional

QuikPass Catheter (K214106) - FDA 510(k) Clearance

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

K214106 · Traverse Vascular, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
30d
Days
Class 2
Risk

K214106 is an FDA 510(k) clearance for the QuikPass Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Traverse Vascular, Inc. (Solana Beach, US). The FDA issued a Cleared decision on January 28, 2022 after a review of 30 days - a notably fast clearance cycle.

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: 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 Traverse Vascular, Inc. devices

Submission Details

510(k) Number K214106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2021
Decision Date January 28, 2022
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

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 - DQY Catheter, Percutaneous

All 390
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K214106.
XO CROSS CORONARY Support Catheter
K214107 · Transit Scientific, LLC · Apr 2022
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K220340 · Abbott Medical · Mar 2022
Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter
K212211 · Vascular Solutions, LLC · Feb 2022
Guiding Catheter
K210009 · CenterPoint Systems, LLC · Nov 2021
XO Cross Support Catheter
K210322 · Transit Scientific, LLC · Oct 2021
Amplatzer Steerable Delivery Sheath
K212026 · Abbott Medical · Sep 2021