Cleared Traditional

K090637 - CARDIO-WRAP

K090637 is an FDA 510(k) clearance for CARDIO-WRAP, manufactured by Mast Biosurgery USA, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 303-day FDA review.

K090637 · Mast Biosurgery USA, Inc. · Cardiovascular device
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Jan 2010
Decision
303d
Days
Class 2
Risk

K090637 is an FDA 510(k) clearance for the CARDIO-WRAP. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Mast Biosurgery USA, Inc. (San Diego, US). The FDA issued a Cleared decision on January 7, 2010 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - 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 Mast Biosurgery USA, Inc. devices

FDA 510(k) Submission Details - K090637

510(k) Number K090637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 10, 2009
Decision Date January 07, 2010
Days to Decision 303 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
178d slower than avg
Panel avg: 125d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXZ Device Classification - Class 2, Special Controls

Product Code DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
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 - DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

All 55
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K090637.
Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch
K200955 · Vascutek, Ltd. · Jul 2020
PremiPatch PTFE Pledget
K151865 · Aesculap, Inc. · Oct 2015
ALBOSURE POLYESTER VASCULAR PATCH
K101740 · LeMaitre Vascular, Inc. · Sep 2010
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
K082139 · Edwards Lifesciences, LLC · Oct 2008
IVENA VASCULAR PATCH
K060396 · Atrium Medical Corp. · May 2006
PTFE FELTS AND PLEDGETS
K041716 · Boston Scientific Corp · Jul 2004