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)
Aug 5, 2013Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Terminated
DYBK791963
Jun 27, 2013Greatbatch Medical
Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14
Terminated
DYBK110051
Jun 27, 2013Terumo Medical Corporation
Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
Terminated
DYBK102008
Jun 27, 2013Terumo Medical Corporation
Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human
Terminated
DYBK091329
Jun 7, 2013Endologix Inc
Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction o
Terminated
DYBK120212
Mar 6, 2013Bard Access Systems
Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630). Product Usage: Hickman and Leonard Catheters are des
Terminated
DYBK830233
Mar 6, 2013Bard Access Systems
Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: H
Terminated
DYBK830233
Dec 28, 2012St Jude Medical Inc
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovas
Terminated
DYBK964518
Dec 22, 2012Greatbatch Medical
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneou
Terminated
DYBK101784
Oct 24, 2012Greatbatch Medical
Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneou
Terminated
DYBK101784
Jan 11, 2012Thomas Medical Products Inc
SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Series, and Situs LDS2 Lead Delivery System - Catalog numbers: CSG/WORLEY/BCor-1-0
Terminated
DYBK003731
Oct 13, 2011Angiodynamics, INC
8F Smart Port CT, Catalog number: CT80STPD and CT80STPD-NF; AngioDynamics, INC. The Smart Port CT Implantable Port is a Single Titanium Port System with Attachable 8.0 Fr. Polyurethane Catheters and
Terminated
DYBK062414
Oct 13, 2011Angiodynamics, INC
8F Safe Sheath Introducer, Catalog number: V18; AngioDynamics, INC. The Valved Introducer sheath is utilized to surgically place the catheter during the port implantation procedure.
Terminated
DYBK073100
Jun 6, 2011Terumo Medical Corporation
Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interven
Terminated
DYBK012812
Jun 6, 2011Terumo Medical Corporation
Pinnacle Destination Guiding Sheath, 6 French, 45 cm, Hockey Stick Tip, Tuohy-Borst Valve, Lot ME07, 510 (K) K012854 Guiding Sheath is used to facilitate the introduction of interventional and diagno
Terminated
DYBK012854
Jun 6, 2011Terumo Medical Corporation
Pinnacle Destination Guiding Sheath, 7 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lots ME07 & MF12, 510(k) K052185 Guiding Sheath is used to facilitate the introduction of interventional and dia
Terminated
DYBK052185
Mar 25, 2011Arrow International Inc
Percutaneous Sheath Introducer Kit Intended usage: Permits venous access and catheter introduction to the central circulation system
Terminated
DYBK780532
Feb 14, 2011Thomas Medical Products Inc
Thomas Medical Products, Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve for use during vascular interventional procedures. SafeSheath Sealing Adapter, Part No. FCL-094-03, Catal
Terminated
DYBK003731
Feb 14, 2011Thomas Medical Products Inc
Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis Valve) for use during vascular interventional procedures. Part No. FCL-051-00, Catalog No. HLS2507M
Terminated
DYBK934901
Feb 4, 2011Arstasis, Inc
Arstasls One Access System; Models: AAD100, AAD101, Part Numbers: FG-02279, FG-03010; The system consists of the following components: (1) Device Sheath/Anchor, (2) Shaft and (3) Handle with control
Terminated
DYBK091006
K100615 +1
Jan 28, 2011Merit Medical Systems, Inc.
Prelude Short Sheath Introducer, 7F-SMT, 4 cm, REF No: PSS-7F-4-038MT, Sterile EO, Merit Medical, South Jordan, Utah. Intended to provide access and facilitate the percutaneous introduction of variou
Terminated
DYBK082063
Jan 21, 2011Arrow International Inc
Super Arrow-Flex(R) PSI Set Intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and
Terminated
DYBK780532
Sep 25, 2010Arrow International Inc
MAC Two-Lumen Central Venous Access kit with Integral Hemostasis Valve for use with 7 - 8 Fr. Catheters
Terminated
DYBK002507
Aug 27, 2010Greatbatch Medical
Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Med
Terminated
DYBK093232
Aug 12, 2010St. Jude Medical Cardiovascular Division
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .038" Max Guidewire O.D., Rx, Sterile EO, REF C408507,100017564.
Terminated
DYBK091137
K092575 +1
Aug 12, 2010St. Jude Medical Cardiovascular Division
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408502, 100017543.
Terminated
DYBK091137
K092575 +1
Aug 12, 2010St. Jude Medical Cardiovascular Division
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549.
Terminated
DYBK091137
K092575 +1
Aug 12, 2010St. Jude Medical Cardiovascular Division
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094.
Terminated
DYBK091137
K092575 +1
Aug 12, 2010St. Jude Medical Cardiovascular Division
St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093.
Terminated
DYBK091137
K092575 +1
Apr 20, 2010Cordis Corporation
Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717. Catalog 504656X Lot # 15076362, 15076363, 15076364.
Terminated
DYBK945616
Mar 10, 2010Baylis Medical Corp *
Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator
Terminated
DYBK013919
Mar 5, 2010Arrow International Inc
Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The p
Terminated
DYBK940079
Mar 5, 2010Arrow International Inc
MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7 - 7.5 Fr Catheters
Terminated
DYBK011761
Mar 4, 2010Thomas Medical Products Inc
Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX, Torflex, Braided Guiding Introducer Kit). The product is shipped 5 per carton. Intended to allow left heart catheterizati
Terminated
DYBK040713
Feb 2, 2010Thomas Medical Products Inc
Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and
Terminated
DYBK003731
Dec 14, 2009Merit Medical Systems, Inc.
Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introducti
Terminated
DYBK082063
Dec 14, 2009Merit Medical Systems, Inc.
Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introduction o
Terminated
DYBK082063
Nov 24, 2009Thomas Medical Products Inc
Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels.
Terminated
DYBK083269
Nov 5, 2009Cordis Corporation
Cordis CROSSOVER. Cordis CROSSOVER Sheath Introducer. Thomas Medical Products, Inc. 65 Great Valley Parkway, Malvern, PA 19355 USA. Distributed by Cordis Corporation, 14201 North West 60th Avenue,
Terminated
DYBK083269
Aug 25, 2009Edwards Lifesciences, Llc
Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion.
Terminated
DYBK981909
Jun 24, 2009Arrow International Inc
Arrow Two-Lumen Central Venous Access (MAC)
Terminated
DYBK002507
Jun 24, 2009Arrow International Inc
Arrow ARROWg+ard Super Arrow-Flex Percutaneous Sheath Introducers
Terminated
DYBK940079
Jun 24, 2009Arrow International Inc
Arrow Super Arrow-Flex Percutaneous Sheath Introducers
Terminated
DYBK924607
Jun 10, 2009Merit Medical Systems, Inc.
8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-8F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facili
Terminated
DYBK082063
Jun 10, 2009Merit Medical Systems, Inc.
8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM, REF No.: PSS-8F-4-038MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and
Terminated
DYBK082063
Jun 10, 2009Merit Medical Systems, Inc.
8F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 7CM Advance Needle; and 0.018" X 40CM NT/PT Guide Wire; REF No.: PSS-8F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South
Terminated
DYBK082063
Jun 10, 2009Merit Medical Systems, Inc.
7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No.: PSS-7F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facili
Terminated
DYBK082063
Jun 10, 2009Merit Medical Systems, Inc.
7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide Wire; REF No.: PSS-7F-4-038MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide
Terminated
DYBK082063
Jun 10, 2009Merit Medical Systems, Inc.
7F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip; 21G X 4CM Advance Needle; and 0.018" X 40CM; REF No.: PSS-7F-4-018MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 840
Terminated
DYBK082063
Jun 10, 2009Merit Medical Systems, Inc.
6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip (No Guide Wire), REF No: PSS-6F-4MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilit
Terminated
DYBK082063

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