Cleared Special

K052282 - VENAFLO II VASCULAR GRAFT

K052282 is an FDA 510(k) clearance for VENAFLO II VASCULAR GRAFT, manufactured by Bard Peripheral Vascular, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Special 510(k) pathway after a 29-day FDA review.

K052282 · Bard Peripheral Vascular, Inc. · Cardiovascular device
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Sep 2005
Decision
29d
Days
Class 2
Risk

K052282 is an FDA 510(k) clearance for the VENAFLO II VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on September 20, 2005 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - the FDA cardiovascular device oversight 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 Bard Peripheral Vascular, Inc. devices

FDA 510(k) Submission Details - K052282

510(k) Number K052282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2005
Decision Date September 20, 2005
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 152
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K052282.
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
K052964 · Boston Scientific Corp · Jan 2006
SWIRLGRAFT BYPASS AND VASCULAR ACCESS GRAFTS
K051312 · Veryan Medical Limited · Nov 2005
ADVANTA T-GRAFT
K051332 · Atrium Medical Corp. · Sep 2005
DYNAFLO BYPASS GRAFT
K050049 · Bard Peripheral Vascular, Inc. · Jan 2005
VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
K043552 · Vascutek, Ltd. · Jan 2005
MODIFICATION TO EPTFE GRAFT
K041528 · Vascutek, Ltd. · Sep 2004