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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 674
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K132030.
SHOOCIN INTRODUCER KIT
K123475 · Lepu Medical Technology (Beijing) Co., Ltd. · Feb 2014
VALVED TEARAWAY INTRODUCER GENERATION II
K132498 · Medcomp (Medical Components, Inc.) · Nov 2013
V-STICK VASCULAR ACCESS SET
K130730 · Argon Medical · Nov 2013
HEARTSPAN STEERABLE INTRODUCER KIT
K132164 · Merit Medical Systems, Inc. · Sep 2013
THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
K131148 · Access Scientific, LLC · Sep 2013
AXERA 2 ACCESS SYSTEM
K132263 · Arstasis, Inc. · Aug 2013
K132030 · MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING
Download PDF FDA Summary Medtronic, Inc.