Cleared Traditional

VSI StraitSet micro-introducer kit (K161336) - FDA 510(k) Clearance

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

K161336 · Vascular Solutions, Inc. · Cardiovascular device
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Aug 2016
Decision
90d
Days
Class 2
Risk

K161336 is an FDA 510(k) clearance for the VSI StraitSet micro-introducer kit. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 11, 2016 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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, Inc. devices

Submission Details

510(k) Number K161336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2016
Decision Date August 11, 2016
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 35
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K161336.
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K183036 · Cook Incorporated · Dec 2018
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K182914 · Mc3 Incorporated · Oct 2018
van Andel Dilatation Catheter
K170616 · Cook Incorporated · Apr 2017
PRELUDE SHEATH INTRODUCER
K130791 · Merit Medical Systems, Inc. · Jun 2013
RETROFLEX DILATOR KIT
K093554 · Edwards Lifesciences, LLC · Apr 2010
MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
K091584 · Merit Medical Systems, Inc. · Oct 2009