Cleared Special

K132164 - HEARTSPAN STEERABLE INTRODUCER KIT

K132164 is an FDA 510(k) clearance for HEARTSPAN STEERABLE INTRODUCER KIT, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 67-day FDA review.

K132164 · Merit Medical Systems, Inc. · Cardiovascular device
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Sep 2013
Decision
67d
Days
Class 2
Risk

K132164 is an FDA 510(k) clearance for the HEARTSPAN STEERABLE INTRODUCER KIT. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Malvern, US). The FDA issued a Cleared decision on September 17, 2013 after a review of 67 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merit Medical Systems, Inc. devices

FDA 510(k) Submission Details - K132164

510(k) Number K132164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2013
Decision Date September 17, 2013
Days to Decision 67 days
Submission Type Special
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
58d faster than avg
Panel avg: 125d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

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 K132164.
INTRODUCER SETS, MODEL ADELANTE RADIAL
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EDWARDS EMBOL-X INTRODUCER SHEATH
K123714 · Edwards Lifesciences, LLC · Jul 2013
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K124046 · Medical Components, Inc. · Jun 2013