Cleared Traditional

K132617 - MEDTRONIC INPUT PS INTRODUCER

K132617 is an FDA 510(k) clearance for MEDTRONIC INPUT PS INTRODUCER, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K132617 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
252d
Days
Class 2
Risk

K132617 is an FDA 510(k) clearance for the MEDTRONIC INPUT PS INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medtronic, Inc. (Danvers, US). The FDA issued a Cleared decision on April 30, 2014 after a review of 252 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 Medtronic, Inc. devices

FDA 510(k) Submission Details - K132617

510(k) Number K132617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2013
Decision Date April 30, 2014
Days to Decision 252 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
127d slower than avg
Panel avg: 125d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 497
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K132617.
INTRODUCER, MODEL ADELANTE MAGNUM
K140917 · Oscor, Inc. · Jul 2014
MICROPUNCTURE INTRODUCER SET
K133114 · Cook Incorporated · Jul 2014
VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA
K140641 · Boston Scientific Corporation · Jul 2014
FLIP INTRODUCER ACCESS KIT
K132789 · Vascular Solutions, Inc. · Apr 2014
DESTINO TWIST, STEERABLE GUIDING SHEATH
K140406 · Oscor, Inc. · Apr 2014
EMBOL-X INTRODUCER SHEATH
K140398 · Edwards Lifesciences, LLC · Mar 2014