Cleared Special

K052578 - BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAV...

K052578 is the FDA 510(k) clearance for BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAV... by Bard Peripheral Vascular, Inc.. It is a Class 2 Cardiovascular device (product code DTK) cleared through the Special 510(k) pathway after a 66-day FDA review.

K052578 · Bard Peripheral Vascular, Inc. · Cardiovascular device
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Nov 2005
Decision
66d
Days
Class 2
Risk

K052578 is an FDA 510(k) clearance for the BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Bard Peripheral Vascular, Inc. (Tempe, US). The FDA issued a Cleared decision on November 25, 2005 after a review of 66 days - a notably fast clearance cycle.

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. 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

Submission Details

510(k) Number K052578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received September 20, 2005
Decision Date November 25, 2005
Days to Decision 66 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 125d · This submission: 66d
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 43
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K052578.
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
VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)
K063217 · B.Braun Medical, Inc. · Jan 2007
MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
K050558 · C.R. Bard, Inc. · Aug 2005
GUNTHER TULIP VENA CAVA FILTER SET
K043509 · Cook, Inc. · May 2005
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
K032426 · Cook, Inc. · Oct 2003