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

Company510(k)sRecalls
Cook Incorporated2067
Terumo Medical Corp.2729
Merit Medical Systems1935
Oscor, Inc.1337
ARROW INTERNATIONAL, LLC037
Abiomed, Inc.628
Thomas Medical Products, Inc.1715
St Jude Medical263
Cordis Corp.223
Boston Scientific166
DateFirm and productCodeLinked 510(k)
Jan 5, 2024Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-0053
Open, Classified		 DYBK192769
Jan 5, 2024Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3052
Open, Classified		 DYBK192769
Jan 5, 2024Abiomed, Inc.
Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the bod
Open, Classified		 DYBK192769
Jan 5, 2024Abiomed, Inc.
Abiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3015
Open, Classified		 DYBK192769
Jan 5, 2024Abiomed, Inc.
Oscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3014
Open, Classified		 DYBK192769
Jan 5, 2024Abiomed, Inc.
Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1
Open, Classified		 DYBK192769
Jul 28, 2023Creganna Medical Devices
Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
Open, Classified		 DYBK152913
Jul 21, 2023Datascope Corp.
REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description
Open, Classified		 DYBK002365
Jul 11, 2023Abiomed, Inc.
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Open, Classified		 DYBK222113
Jun 15, 2023Galt Medical Corporation
Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
Open, Classified		 DYBK153533
Jun 15, 2023Galt Medical Corporation
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Open, Classified		 DYBK153533
May 10, 2023Merit Medical Systems, Inc.
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Open, Classified		 DYBK070159
Apr 1, 2023Biosense Webster, Inc.
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
Open, Classified		 DYBK170997
Apr 1, 2023Biosense Webster, Inc.
Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Small), REF D-1385-01-S, RX CE 2797, Sterile
Open, Classified		 DYBK170997
Jun 29, 2022Biosense Webster, Inc.
CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Open, Classified		 DYBK170997
Feb 21, 2022Freudenberg Medical, Llc
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Terminated		 DYBK190628
Feb 21, 2022Freudenberg Medical, Llc
Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Terminated		 DYBK190628
Dec 22, 2021Oscor Inc.
Destino Twist 14F (also branded as Guidestar 14F)
Completed		 DYBK140406
Nov 16, 2021Abbott
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Terminated		 DYBNone listed
Nov 12, 2021Cook Inc.
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44155 Intended to introduce therapeutic or diagnostic devices into the vasculature, exclu
Terminated		 DYBK142829
Nov 12, 2021Cook Inc.
Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excl
Terminated		 DYBK142829
Sep 28, 2021Cook Inc.
Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-38-90-RB-RAABE, GPN G13069 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve
Terminated		 DYBK142829
Sep 28, 2021Cook Inc.
Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dila
Terminated		 DYBK142829
Jul 21, 2021Merit Medical Systems, Inc.
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
Terminated		 DYBK082063
Jul 8, 2021Argon Medical Devices, Inc
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
Open, Classified		 DYBK202141
Jun 30, 2021Merit Medical Systems, Inc.
Prelude SNAP Splittable Sheath Introducer, REF: PLS-1007, size 7F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, UDI:(01) 00884450467985. For the introduction of various types of pacing leads
Terminated		 DYBK143255
Jun 30, 2021Merit Medical Systems, Inc.
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads an
Terminated		 DYBK143255
Mar 10, 2021Oscor, Inc.
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Terminated		 DYBNone listed
Feb 26, 2021Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuver
Completed		 DYBK170997
Feb 26, 2021Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuvera
Completed		 DYBK170997
Feb 26, 2021Biosense Webster, Inc.
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuvera
Completed		 DYBK170997
Feb 22, 2021Angiodynamics Inc. (Navilyst Medical Inc.)
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Terminated		 DYBK122084
Dec 23, 2020Cook Inc.
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-6.0-38-90-RB-SHTL-FLEX-HC, Order Number G31138 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagn
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-SHTL-FLEX-HC, Order Number G31133 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagn
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G56228 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G56223 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G49045 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G56233 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G56227 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL0-HC, Order Number G56222 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL1-HC, Order Number G49043 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-7.0-35-55-RB-HFANL0-HC, Order Number G56232 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G56226 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G56221 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G56236 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G56231 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL1-HC, Order Number G56225 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G56220 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL1-HC, Order Number G56235 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829
Dec 23, 2020Cook Inc.
Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculat
Terminated		 DYBK142829

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