Cleared Traditional

K132293 - SYVEK RADIAL BAND

K132293 is an FDA 510(k) clearance for SYVEK RADIAL BAND, manufactured by Marine Polymer Technologies. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K132293 · Marine Polymer Technologies · Cardiovascular device
Download Printable Device Report (PDF)
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Jul 2014
Decision
373d
Days
Class 2
Risk

K132293 is an FDA 510(k) clearance for the SYVEK RADIAL BAND. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Marine Polymer Technologies (Danvers, US). The FDA issued a Cleared decision on July 31, 2014 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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. Elevated predicate reliance profile. 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 Marine Polymer Technologies devices

FDA 510(k) Submission Details - K132293

510(k) Number K132293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2013
Decision Date July 31, 2014
Days to Decision 373 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
248d slower than avg
Panel avg: 125d · This submission: 373d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 94
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K132293.
IntraClude Intra-Aortic Occlusion Device
K163693 · Edwards Lifesciences, LLC · Jan 2017
PreludeSYNC Radial Compression Device
K162988 · Merit Medical Systems, Inc. · Jan 2017
TRAcelet Compression Device
K162027 · Medtronic Vascular · Oct 2016
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K132175 · Edwards Lifesciences, LLC · Sep 2013
HEARTSTRING III PROXIMAL SEAL SYSTEM
K130382 · Boston Scientific Corporation · Jun 2013
MICROFRANCE(R) WORMALD VASCULAR CLAMP
K112662 · Medtronic Xomed, Inc. · Jan 2012