BEUDAMED
    Product Code: DTK FDA class 2 21 CFR 870.3375

    Filter, Intravascular, Cardiovascular

    Cardiovascular

    The Intravascular Cardiovascular Filter is an implantable cardiovascular device placed within a blood vessel to trap and prevent the passage of emboli, thrombi, or other particulate matter, protecting downstream organs or tissues from occlusion. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTK and it is regulated under 21 CFR 870.3375 within the Cardiovascular medical specialty. This device is flagged as an implant.

    View on FDA
    510(k)s
    83
    FEI Numbers
    22
    Registration Numbers
    22
    Unique Applicants
    29
    Years Active
    48

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    Basic Information

    Product Code
    DTK
    Device Class
    FDA class 2
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 83 510(k) clearances via K numbers.

    K Number Device Name
    K242612 Option ELITE Vena Cava Filter System (352506070E 352506100E)
    K240578 VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
    K241507 ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)
    K240257 Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit
    K233680 Celect 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 Filter
    K211875 Cook 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
    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
    K181202 Sentry IVC Filter
    K173236 Sentry IVC Filter
    K172584 Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
    K172557 Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
    K163699 ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with Hook
    K171712 Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach
    K162875 Sentry IVC filter
    K161218 Gianturco-Roehm Bird’s Nest Vena Cava Filter
    K160866 Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit
    K152765 VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM
    K143405 Option (TM) ELITE Vena Cava Filter 100cm System
    K150262 Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugular
    K143208 Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit
    K140286 OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
    K133243 OPTION ELITE VENA CAVA FILTER SYSTEM
    K130366 BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT
    K122585 CRUX VENA CAVA FILTER SYSTEM
    K113124 ALN OPTIONAL VANA CAVA FILTER
    K120402 CRUX VENA CAVA FILTER SYSTEM
    K121629 COOK CELECT PLATINUM VENA CAVA FILTER SET FOR FEMORAL APPROACH COOK CELECT PLATIUM VENA CAVA FILTER SET FOR JUGULAR APPR
    K121057 COOK CELECT AND GUNTHER TULIP VENA CAVA FILTER SETS
    K112119 CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH
    K112497 MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
    K102511 MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT
    K101431 ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
    K091077 OPTEASE VENA CAVA FILTER AND RETRIEVAL CATHETER
    K093659 ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5
    K081410 OPTION VENA CAVA FILTER
    K081138 SAFEFLO VENA CAVA FILTER
    K090140 GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER
    K082305 G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
    K080668 G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS
    K073374 COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
    K073528 VENA CAVA FILTER
    K070514 ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO
    K073090 RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J
    K072240 GUNTHER TULIP VENA CAVA FILTER
    K061815 COOK CELECT VENA CAVA FILTER
    K063217 VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL)
    K062887 MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F
    K052578 BARD G2 FILTER SYSTEM - JUGULAR/SUBCLAVIAN DELIVERY KIT, MODEL RF-320J
    K050558 MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F
    K043509 GUNTHER TULIP VENA CAVA FILTER SET
    K034050 CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F
    K032426 GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
    K031328 RECOVERY FILTER SYSTEM, MODEL RF-048F
    K022236 RECOVERY FILTER SYSTEM, MODEL RF-048F
    K023116 CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B
    K010083 TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
    K010485 VENA TECH VENA CAVA FILTER; VENA TECH 30D VENA CAVA FILTER; VENA TECH LP CAVE FILTER
    K003964 TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B
    K000855 GUNTHER TULIP VENA CAVA MREYE FILTER SET
    K000062 CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT
    K970099 SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
    K964284 STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM
    K963016 SIMON NITINOL FILTER SYSTEM
    K963014 SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
    K955396 STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER SYSTEM
    K951508 STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM
    K912035 STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY
    K944353 SIMON NITINOL FILTER
    K940489 SIMON NITINOL FILTER
    K932921 PERCUTANEOUS INTRODUCER FOR VENA CAVA FILTER SYST
    K925679 VENA CAVA FILTER SYSTEMS, MODIFICATION
    K912144 SIMON NITINOL FILTER, MODIFICATION
    K901454 VENA CAVA FILTER
    K901659 TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
    K901235 GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER
    K894703 SIMON NITINOL FILTER
    K881604 VENA CAVA FILTER
    K874096 TITANIUM GREENFIELD VENA CAVA FILTER CARRIER
    K870729 TITANIUM PERCUTANEOUS GREENFIELD VENA CAVE FILTER
    K852097 PERCUTANEOUS GREENFIELD VENA CAVA FILTER SYSTEM
    K771046 VENA CAVA UMBRELLA FILTER, MODEL 7321
    K760151 APPLICATOR,ANGIOGRAPHY (7310MOBIN-UDDIN)
    K760152 FILTER (7220&7221 MOBIN-UDDIN VENA CAVA)

    FEI Numbers

    This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.