Cleared Traditional

K133114 - MICROPUNCTURE INTRODUCER SET

K133114 is the FDA 510(k) clearance for MICROPUNCTURE INTRODUCER SET by Cook Incorporated. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K133114 · Cook Incorporated · Cardiovascular device
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Jul 2014
Decision
276d
Days
Class 2
Risk

K133114 is an FDA 510(k) clearance for the MICROPUNCTURE INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 3, 2014 after a review of 276 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Cook Incorporated devices

Submission Details

510(k) Number K133114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date July 03, 2014
Days to Decision 276 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
151d slower than avg
Panel avg: 125d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 318
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K133114.
PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER
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K132592 · Cook, Inc. · Oct 2014
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K140513 · Merit Medical Systems, Inc. · Jul 2014
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
K140641 · Boston Scientific Corporation · Jul 2014
MEDTRONIC INPUT PS INTRODUCER
K132617 · Medtronic, Inc. · Apr 2014
FLIP INTRODUCER ACCESS KIT
K132789 · Vascular Solutions, Inc. · Apr 2014