Cleared Traditional

K162181 - Protek Duo Venous Dilator Set

K162181 is the FDA 510(k) clearance for Protek Duo Venous Dilator Set by Cardiacassist, Inc.. It is a Class 2 Cardiovascular device (product code DRE) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K162181 · Cardiacassist, Inc. · Cardiovascular device
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Jan 2017
Decision
155d
Days
Class 2
Risk

K162181 is an FDA 510(k) clearance for the Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on January 6, 2017 after a review of 155 days - an extended review cycle.

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 Cardiacassist, Inc. devices

Submission Details

510(k) Number K162181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2016
Decision Date January 06, 2017
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
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 44
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K162181.
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van Andel Dilatation Catheter
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VSI StraitSet micro-introducer kit
K161336 · Vascular Solutions, Inc. · Aug 2016
NMI COAXIAL MICROINTRODUCER SET
K132713 · Navilyst Medical, Inc. · Sep 2013
PRELUDE SHEATH INTRODUCER
K130791 · Merit Medical Systems, Inc. · Jun 2013