Cleared Traditional

K182570 - Venture 0.014 Catheter

K182570 is an FDA 510(k) clearance for Venture 0.014 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 176-day FDA review.

K182570 · Vascular Solutions, LLC · Cardiovascular device
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Mar 2019
Decision
176d
Days
Class 2
Risk

K182570 is an FDA 510(k) clearance for the Venture 0.014 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 March 13, 2019 after a review of 176 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 - K182570

510(k) Number K182570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2018
Decision Date March 13, 2019
Days to Decision 176 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
51d slower than avg
Panel avg: 125d · This submission: 176d
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 620
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K182570.
Route 92 Medical Delivery Catheter
K190431 · Route 92 Medical, Inc. · Mar 2019
SelectSite C304-HIS Deflectable Catheter System
K183493 · Medtronic, Inc. · Mar 2019
MAMBA and MAMBA Flex Microcatheters
K190401 · Boston Scientific Corporation · Mar 2019
AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm
K183463 · Stryker · Mar 2019
ViperCath XC Peripheral Exchange Catheter
K183000 · Cardiovascular Systems, Inc. · Dec 2018
ASAHI Corsair Pro XS
K182420 · Asahi Intecc Co., Ltd. · Dec 2018