Cleared Traditional

K060396 - IVENA VASCULAR PATCH

K060396 is an FDA 510(k) clearance for IVENA VASCULAR PATCH, manufactured by Atrium Medical Corp.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K060396 · Atrium Medical Corp. · Cardiovascular device
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May 2006
Decision
86d
Days
Class 2
Risk

K060396 is an FDA 510(k) clearance for the IVENA VASCULAR PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on May 12, 2006 after a review of 86 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Atrium Medical Corp. devices

FDA 510(k) Submission Details - K060396

510(k) Number K060396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2006
Decision Date May 12, 2006
Days to Decision 86 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 125d · This submission: 86d
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 50
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K060396.
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
PTFE FELTS AND PLEDGETS
K041716 · Boston Scientific Corp · Jul 2004
CHASE CARDIOVASCULAR PATCH KIT
K022093 · Chase Medical, Inc. · Sep 2002
CHARE CARIOVASCULAR PATCH
K021129 · Chase Medical, Inc. · Jun 2002