Cleared Traditional

K132030 - MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING

K132030 is an FDA 510(k) clearance for MICRA INTRODUCER SHEATH WITH HYDROPHILI..., 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 88-day FDA review.

K132030 · Medtronic, Inc. · Cardiovascular device
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Sep 2013
Decision
88d
Days
Class 2
Risk

K132030 is an FDA 510(k) clearance for the MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on September 27, 2013 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic, Inc. devices

FDA 510(k) Submission Details - K132030

510(k) Number K132030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2013
Decision Date September 27, 2013
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 K132030.
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EDWARDS EMBOL-X INTRODUCER SHEATH
K123714 · Edwards Lifesciences, LLC · Jul 2013