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

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
Combination Product No
PCCP Authorized No
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 192
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K132293.
RADAR VASCULAR COMPRESSION DEVICE
K142122 · Advanced Vascular Dynamics · Dec 2014
Vasc Band hemostat
K142359 · Lepu Medical Technology (Beijing) Co., Ltd. · Oct 2014
ITCLAMP 50
K140805 · Innovative Trauma Care, Inc. · Oct 2014
ABDOMINAL AORTIC AND JUNCTIONAL TOURNIQUET (AAJT) DEVICE
K133029 · Compression Works, LLC · Dec 2013
ITCLAMP 50
K132651 · Innovative Trauma Care, Inc. · Oct 2013
COSEAL
K131411 · Jilin Coronado Medical , Ltd. · Sep 2013