Cleared Traditional

K091626 - CRYOPATCH SG PULMONARY HEMI-ARTERY

Also marketed or referenced as:
TRUNK BRANCH

K091626 is the FDA 510(k) clearance for CRYOPATCH SG PULMONARY HEMI-ARTERY by Cryolife, Inc.. It is a Class 2 Cardiovascular device (product code DXZ) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K091626 · Cryolife, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
65d
Days
Class 2
Risk

K091626 is an FDA 510(k) clearance for the CRYOPATCH SG PULMONARY HEMI-ARTERY. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Cryolife, Inc. (Kennesaw, US). The FDA issued a Cleared decision on August 7, 2009 after a review of 65 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 Cryolife, Inc. devices

Submission Details

510(k) Number K091626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2009
Decision Date August 07, 2009
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 36
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K091626.
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