ClearanceBrief
Panels › Cardiovascular › Product code DYB · Class 2

Introducer, Catheter

Regulation 870.1340

19510(k)s in 12 months (707 all time)
27recalls in 12 months (389 all time)
337recalls that name a 510(k)
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Top companies in DYB

DateFirm and productCodeLinked 510(k)
Oct 5, 2016Oscor, Inc.
OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C120 S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punc
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C90 S79CM D84CM Catalog # AB101078 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C70 S79CM D84CM Catalog # AB101077 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C55 S79CM D84CM Catalog # AB101076 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C120 S61CM D66CM Catalog # AB101075 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punc
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C70 S61CM D66CM Catalog # AB101073 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 10F C55 S61CM D66CM Catalog # AB101072 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal pu
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal p
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C120 S79CM D84CM Catalog # AB081047 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C90 S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctur
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C70 S79CM D84CM Catalog # AB081045 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C55 S79CM D84CM Catalog # AB081044 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C120 S61CM D66CM Catalog # AB081043 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punct
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C90 S61CM D66CM Catalog # AB081042 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C70 S61CM D66CM Catalog # AB081041 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu
Terminated
DYBK101497
K122958
Oct 5, 2016Oscor, Inc.
OSCOR ADELANTE BREEZEWAY 8F C55 S61CM D66CM Catalog # AB081040 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal punctu
Terminated
DYBK101497
K122958
Sep 28, 2016Angiodynamics, Inc.
ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a sm
Terminated
DYBK051655
Sep 28, 2016Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stif
Terminated
DYBK051655
Sep 28, 2016Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffen
Terminated
DYBK051655
Sep 28, 2016Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened
Terminated
DYBK051655
Sep 28, 2016Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened M
Terminated
DYBK051655
Sep 28, 2016Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened M
Terminated
DYBK051655
Sep 28, 2016Angiodynamics, Inc.
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened
Terminated
DYBK051655
Sep 6, 2016Terumo Medical Corporation
PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer Sheath
Terminated
DYBK111606
Aug 22, 2016Cook Inc.
Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
Terminated
DYBNone listed
Jun 7, 2016Medical Components, Inc dba MedComp
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tea
Terminated
DYBK130687
Jan 20, 2016Cook Inc.
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional
Terminated
DYBNone listed
Jan 12, 2016Arrow International Inc
Super Arrow-Flex Percutaneous Sheath Introducer Sets REF CL-07035 or CL-07635 or CL-07735 or CL-07835 Super Arrow-Flex Percutaneous Sheath Introducer Set with Integral Hemostasis Valve/Side Port and
Terminated
DYBK924607
Dec 18, 2015Boston Scientific Corporation
Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene oxide: Product Description Material Number (UPN) Guiding Sheath 5F, 45 cm, ST, CC H74939277545110 Guiding Sheath 5F, 45 cm,
Terminated
DYBK150186
Dec 14, 2015Stryker Instruments Div. of Stryker Corporation
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall
Terminated
DYBK812973
Jul 18, 2015Cook Inc.
Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional device
Terminated
DYBNone listed
Mar 17, 2015Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of t
Terminated
DYBK142684
Oct 22, 2014St Jude Medical
St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), She
Terminated
DYBK954317
Sep 4, 2014Galt Medical Corporation
GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravasc
Terminated
DYBK112398
Sep 4, 2014Galt Medical Corporation
GALT VALVED TEARAWAY INTRODUCER SET GALT VTI RX ONLY UNITS 7 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral
Terminated
DYBK112398
Jun 4, 2014Arrow International Inc
Arrow Percutaneous Sheath Introducer Kits The Percutaneous sheath introducer products permit venous or arterial access and device introduction to the central circulation.
Terminated
DYBK780532
May 13, 2014Greatbatch Medical
Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 1063
Terminated
DYBK990705
Mar 27, 2014Biocardia, Inc.
Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through me
Terminated
DYBK090999
Mar 27, 2014Biocardia, Inc.
Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medi
Terminated
DYBK090999
Feb 19, 2014Biocardia, Inc.
MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to
Terminated
DYBK090999
Dec 21, 2013B. Braun Medical, Inc.
B. Braun Introcan Safety IV Catheter PUR 24G, 0.7X19mm-US, catalog number 4251601-02. Product Usage: The B. Braun Introcan Safety IV Catheter is a passive anti-stick device to provide venous or a
Terminated
DYBK021094
Dec 9, 2013Arrow International Inc
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
Terminated
DYBK112554
K780532
Nov 1, 2013Baylis Medical Corp *
Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three com
Terminated
DYBK102948
Sep 23, 2013Smiths Medical ASD, Inc.
Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems are designed to p
Terminated
DYBK871132
Sep 18, 2013Access Scientific Inc
POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006. Used to gain access to the vascular system to sample blood and administer fluids intravenously.
Terminated
DYBK111417
K121748 +1

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