Cleared Traditional

K053300 - SYVEKEXCEL

K053300 is an FDA 510(k) clearance for SYVEKEXCEL, manufactured by Marine Polymer Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K053300 · Marine Polymer Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
123d
Days
Class 2
Risk

K053300 is an FDA 510(k) clearance for the SYVEKEXCEL. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Marine Polymer Technologies, Inc. (Danvers, US). The FDA issued a Cleared decision on March 28, 2006 after a review of 123 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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, Inc. devices

FDA 510(k) Submission Details - K053300

510(k) Number K053300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2005
Decision Date March 28, 2006
Days to Decision 123 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
2d faster than avg
Panel avg: 125d · This submission: 123d
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 K053300.
D-STAT HANDLE, MODEL 8500-053
K063871 · Vascular Solutions, Inc. · Feb 2007
TEMPORARY LIMB SALVAGE SHUNT
K070323 · Vascutek, Ltd. · Feb 2007
SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
K062569 · Datascope Corp. · Feb 2007
VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY
K050146 · Vascular Solutions, Inc. · May 2005
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
K040730 · Vascular Solutions, Inc. · Jun 2004
FEMOSTOP FEMORAL COMPRESSION SYSTEM
K024107 · Radi Medical Systems AB · Dec 2002