Cleared Special

K043509 - GUNTHER TULIP VENA CAVA FILTER SET

K043509 is an FDA 510(k) clearance for GUNTHER TULIP VENA CAVA FILTER SET, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DTK cleared through the Special 510(k) pathway after a 136-day FDA review.

K043509 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
136d
Days
Class 2
Risk

K043509 is an FDA 510(k) clearance for the GUNTHER TULIP VENA CAVA FILTER SET. Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on May 5, 2005 after a review of 136 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.

FDA 510(k) Submission Details - K043509

510(k) Number K043509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2004
Decision Date May 05, 2005
Days to Decision 136 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
11d slower than avg
Panel avg: 125d · This submission: 136d
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 82
Devices cleared under the same product code (DTK) and FDA review panel - the closest regulatory comparables to K043509.
MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F
K062887 · Bard Peripheral Vascular · Oct 2006
BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
K052578 · Bard Peripheral Vascular, Inc. · Nov 2005
MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
K050558 · C.R. Bard, Inc. · Aug 2005
CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B
K034050 · Cordis Corporation · Mar 2004
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
K032426 · Cook, Inc. · Oct 2003
RECOVERY FILTER SYSTEM, MODEL RF-048F
K031328 · C.R. Bard, Inc. · Jul 2003
K043509 · GUNTHER TULIP VENA CAVA FILTER SET
Download PDF FDA Summary Cook, Inc.