Cleared Special

K101431 - ECLIPSE FILTER SYSTEM-FEMORAL AND JUGUL...

K101431 is the FDA 510(k) clearance for ECLIPSE FILTER SYSTEM-FEMORAL AND JUGUL... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DTK) cleared through the Special 510(k) pathway after a 35-day FDA review.

K101431 · C.R. Bard, Inc. · Cardiovascular device
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Jun 2010
Decision
35d
Days
Class 2
Risk

K101431 is an FDA 510(k) clearance for the ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS. 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 June 25, 2010 after a review of 35 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K101431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2010
Decision Date June 25, 2010
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
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 K101431.
BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
K130366 · C.R. Bard, Inc. · May 2013
MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
K112497 · C.R. Bard, Inc. · Oct 2011
MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
K102511 · C.R. Bard, Inc. · Aug 2011
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
G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
K080668 · C.R. Bard, Inc. · Jul 2008