Cleared Traditional

K102511 - MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT

K102511 is an FDA 510(k) clearance for MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLA..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K102511 · C.R. Bard, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2011
Decision
357d
Days
Class 2
Risk

K102511 is an FDA 510(k) clearance for the MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT. 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 August 24, 2011 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K102511

510(k) Number K102511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2010
Decision Date August 24, 2011
Days to Decision 357 days
Submission Type Traditional
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
232d slower than avg
Panel avg: 125d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTK Device Classification - Class 2, Special Controls

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 60
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K102511.
COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
K121057 · William Cook Europe Aps · May 2012
CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH
K112119 · William Cook Europe Aps · Mar 2012
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K112497 · C.R. Bard, Inc. · Oct 2011
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
GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER
K090140 · William Cook Europe Aps · Apr 2009