Cleared Special

K063644 - CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM

K063644 is an FDA 510(k) clearance for CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM, manufactured by Cardica, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Special 510(k) pathway after a 35-day FDA review.

K063644 · Cardica, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
35d
Days
Class 2
Risk

K063644 is an FDA 510(k) clearance for the CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM. Classified as Clip, Implantable (product code FZP), Class II - Special Controls.

Submitted by Cardica, Inc. (Redwood City, US). The FDA issued a Cleared decision on January 11, 2007 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cardica, Inc. devices

FDA 510(k) Submission Details - K063644

510(k) Number K063644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2006
Decision Date January 11, 2007
Days to Decision 35 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

FZP Device Classification - Class 2, Special Controls

Product Code FZP Clip, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FZP Clip, Implantable

All 105
Devices cleared under the same product code (FZP) and FDA review panel - the closest regulatory comparables to K063644.
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K062821 · Medtronic Neurosurgery · Dec 2006
AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
K061288 · United States Surgical, A Division of Tyco Healthc · Nov 2006
HEM-O-LOK LIGATION CLIP
K062914 · Teleflex Medical · Nov 2006