Cleared Special

K211874 - Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K211874 · William Cook Europe Aps · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2021
Decision
41d
Days
Class 2
Risk

K211874 is an FDA 510(k) clearance for the Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip V.... Classified as Filter, Intravascular, Cardiovascular (product code DTK), Class II - Special Controls.

Submitted by William Cook Europe Aps (Bjaeverskov, DK). The FDA issued a Cleared decision on July 28, 2021 after a review of 41 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 William Cook Europe Aps devices

Submission Details

510(k) Number K211874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2021
Decision Date July 28, 2021
Days to Decision 41 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
84d faster than avg
Panel avg: 125d · This submission: 41d
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 82
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