Cleared Traditional

K081225 - CARDICA PAS-PORT PROXIMAL ANASTOMOSIS S...

K081225 is an FDA 510(k) clearance for CARDICA PAS-PORT PROXIMAL ANASTOMOSIS S..., manufactured by Cardica, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FZP cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K081225 · Cardica, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
128d
Days
Class 2
Risk

K081225 is an FDA 510(k) clearance for the CARDICA PAS-PORT PROXIMAL 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 September 5, 2008 after a review of 128 days - within the typical 510(k) review window.

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. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardica, Inc. devices

FDA 510(k) Submission Details - K081225

510(k) Number K081225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2008
Decision Date September 05, 2008
Days to Decision 128 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 115d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K081225.
ENDOSCOPIC CLIP SYSTEM
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K093679 · AtriCure, Inc. · Jun 2010
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
K091987 · LeMaitre Vascular, Inc. · Apr 2010
U-CLIP UNI-FIRE, MODEL M65
K081082 · Medtronic, Inc. · May 2008
ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE
K081031 · Aesculap, Inc. · May 2008
AESCULAP ENDOSCOPIC CLIP SYTEM
K080753 · Aesculap, Inc. · Apr 2008