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FDA 510(k)

COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS

K-Number: K121057 · 2012-05-04

ApplicantWilliam Cook Europe Aps
Decision Date2012-05-04
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS is the device name listed in this FDA 510(k) record. The listed applicant is William Cook Europe Aps. It received FDA 510(k) clearance on 2012-05-04 under 510(k) number K121057. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS?

COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS is a medical device that received FDA 510(k) clearance on 2012-05-04. The listed applicant is William Cook Europe Aps. The 510(k) number is K121057.

When did COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS receive FDA 510(k) clearance?

COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS received FDA 510(k) clearance on 2012-05-04, under 510(k) number K121057.

Who is the listed applicant for COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS?

The FDA 510(k) record lists William Cook Europe Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS?

The FDA product code for COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS is DTK.

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Other records listing William Cook Europe Aps as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251596Lunderquist Extra Stiff Wire GuideK251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)K233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava FilterK220137Lunderquist Extra Stiff Wire GuideK211874Günther 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 ApproachK211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach

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Related Devices (Code: DTK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc.K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc.K241507ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)Aln S.A.R.L.K240257Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery KitBdK233680Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT); Celect Platinum Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-CELECT-PT); Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach (IGTCFS-65-1-UNI-CELECT-PT); Günther Tulip Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-TULIP); Günther Tulip Vena Cava Filter Set for Jugular Vein Approach (IGTCFS-65-1-JUG-TULIP); Günther Tulip Vena Cava FilterWilliam Cook Europe ApsK211874Günther 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 ApproachWilliam Cook Europe Aps

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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