Cleared Traditional

K193119 - Twin-Pass Dual Access Catheter

K193119 is an FDA 510(k) clearance for Twin-Pass Dual Access Catheter, manufactured by Vascular Solutions, LLC. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K193119 · Vascular Solutions, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
230d
Days
Class 2
Risk

K193119 is an FDA 510(k) clearance for the Twin-Pass Dual Access Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Vascular Solutions, LLC (Minneapolis, US). The FDA issued a Cleared decision on June 29, 2020 after a review of 230 days - an extended review 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: 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 Vascular Solutions, LLC devices

FDA 510(k) Submission Details - K193119

510(k) Number K193119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2019
Decision Date June 29, 2020
Days to Decision 230 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
105d slower than avg
Panel avg: 125d · This submission: 230d
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 621
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K193119.
NHancer Rx
K200324 · Imds Operations B.V. · Aug 2020
Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter
K192712 · Medtronic, Inc. · Aug 2020
BOBBY Balloon Guide Catheter
K193607 · MicroVention, Inc. · Jul 2020
Benchmark BMX96 Access System
K201271 · Penumbra, Inc. · Jun 2020
Agilis HisPro Steerable Catheter With Electrodes
K200721 · Abbott (St. Jude Medical) · Jun 2020
Support Catheter
K200317 · Qxmedical, LLC · May 2020