Cleared Special

K080668 - G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400...

K080668 is the FDA 510(k) clearance for G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DTK) cleared through the Special 510(k) pathway after a 142-day FDA review.

K080668 · C.R. Bard, Inc. · Cardiovascular device
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Jul 2008
Decision
142d
Days
Class 2
Risk

K080668 is an FDA 510(k) clearance for the G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DEL.... Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on July 30, 2008 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K080668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2008
Decision Date July 30, 2008
Days to Decision 142 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
17d slower than avg
Panel avg: 125d · This submission: 142d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DTK Filter, Intravascular, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3375
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 - DTK Filter, Intravascular, Cardiovascular

All 39
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K080668.
ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
K101431 · C.R. Bard, Inc. · Jun 2010
ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
K093659 · C.R. Bard, Inc. · Jan 2010
G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
K082305 · C.R. Bard, Inc. · Oct 2008
VENA CAVA FILTER
K073528 · Cook Incorporated · Feb 2008
RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F
K073090 · C.R. Bard, Inc. · Jan 2008
GUNTHER TULIP VENA CAVA FILTER
K072240 · Cook, Inc. · Nov 2007