Cleared Special

K112497 - MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT

K112497 is an FDA 510(k) clearance for MERIDIAN FILTER SYSTEM - FEMORAL DELIVE..., manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Special 510(k) pathway after a 56-day FDA review.

K112497 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
56d
Days
Class 2
Risk

K112497 is an FDA 510(k) clearance for the MERIDIAN FILTER SYSTEM - FEMORAL 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 October 24, 2011 after a review of 56 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

FDA 510(k) Submission Details - K112497

510(k) Number K112497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2011
Decision Date October 24, 2011
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

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 K112497.
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K093659 · C.R. Bard, Inc. · Jan 2010