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 10, 2026Terumo Medical Corporation
GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.
Open, Classified
DYBK173831
Jul 10, 2026Abiomed, Inc.
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jul 10, 2026Abiomed, Inc.
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jul 10, 2026Abiomed, Inc.
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jul 10, 2026Abiomed, Inc.
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jul 10, 2026Abiomed, Inc.
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jul 10, 2026Abiomed, Inc.
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jul 10, 2026Abiomed, Inc.
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jul 10, 2026Abiomed, Inc.
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jul 10, 2026Abiomed, Inc.
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jul 10, 2026Abiomed, Inc.
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jul 10, 2026Abiomed, Inc.
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jul 10, 2026Oscor Inc.
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
Open, Classified
DYBK122084
Jul 10, 2026Oscor Inc.
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
Open, Classified
DYBK122084
Jul 10, 2026Oscor Inc.
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
Open, Classified
DYBK122084
Jul 10, 2026Abiomed, Inc.
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jul 10, 2026Abiomed, Inc.
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories
Open, Classified
DYBK192769
K201116
Jun 25, 2026Abiomed, Inc.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Open, Classified
DYBK241708
Jun 25, 2026Abiomed, Inc.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Open, Classified
DYBK241708
Jun 25, 2026Abiomed, Inc.
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Open, Classified
DYBK241708
Jun 25, 2026Abiomed, Inc.
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Open, Classified
DYBK241708
Jun 13, 2026ARROW INTERNATIONAL, LLC
Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9 FR/AK-09903-CDC; PSI KIT: 8.5 FR X 4 IN (10 CM)/ASK-09810-PCMH1; PSI KIT: 9 FR X 10 CM/ASK-09903-KH; PSI KIT: 9 FR X 10
Open, Classified
DYBK002507
K011761 +2
May 15, 2026Becton, Dickinson and Company
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
Open, Classified
DYBK231248
K233824
Mar 26, 2026Merit Medical Systems, Inc.
16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B
Open, Classified
DYBK043438
Dec 23, 2025Cook Incorporated
Rsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The Rsch-Uchida Transjugular Liver Access Set is intended for transjugular liver access in diagnostic and interventional
Open, Classified
DYBK171820
Dec 23, 2025Cook Incorporated
Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2) RTPS-100-10.0; The Ring Transjugular Intrahepatic Access Set is intended for transjugular liver access in diagno
Open, Classified
DYBK171820
Dec 23, 2025Cook Incorporated
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC;
Open, Classified
DYBK142829
Sep 5, 2025Contract Medical International GmbH
Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm:
Open, Classified
DYBK153197
May 16, 2025Cook Incorporated
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Open, Classified
DYBNone listed
May 16, 2025Cook Incorporated
Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,
Open, Classified
DYBK171999
May 7, 2025Galt Medical Corporation
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV Introducer System is indicated for use in percutaneous procedures to introduce cath
Open, Classified
DYBK043525
Mar 24, 2025Merit Medical Systems, Inc.
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Open, Classified
DYBK173750
Jan 29, 2025MEDLINE INDUSTRIES, LP - Northfield
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
Open, Classified
DYBK885179
Oct 9, 2024Cook Incorporated
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with
Open, Classified
DYBK171999
Aug 12, 2024Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-C
Open, Classified
DYBK120158
Aug 12, 2024Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PL
Open, Classified
DYBK152381
Aug 12, 2024Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP (Introducer Catheter kit), REF: For the introduction of various types
Open, Classified
DYBK143255
Aug 12, 2024Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude Prestige (Introducer Catheter), REF: PLP-2505/A PLP-2514/A PLP-2516/A The in
Open, Classified
DYBK172117
Aug 12, 2024Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A Fo
Open, Classified
DYBK120158
Jul 12, 2024St. Jude Medical
St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Open, Classified
DYBK061363
Jun 27, 2024Merit Medical Systems, Inc.
Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP -PG5F90S -PG5F90S018 -PG6F45HS -PG6F45MP -PG6F45R -PG6F45S -PG6F45S018 -PG6F65MP -PG6F65S -PG6F65
Open, Classified
DYBK211405
May 20, 2024Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Open, Classified
DYBK211405
May 20, 2024Merit Medical Systems, Inc.
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Open, Classified
DYBK211405
Apr 12, 2024Cook Incorporated
Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFE
Open, Classified
DYBNone listed
Mar 28, 2024Boston Scientific Corporation
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Open, Classified
DYBK180785
K191871 +2
Mar 13, 2024Biosense Webster, Inc.
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerabl
Open, Classified
DYBK170997
Jan 5, 2024Abiomed, Inc.
Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
Open, Classified
DYBNone listed
Jan 5, 2024Abiomed, Inc.
Abiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024, 0048-0032)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3056
Open, Classified
DYBNone listed
Jan 5, 2024Abiomed, Inc.
Oscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3025
Open, Classified
DYBNone listed
Jan 5, 2024Abiomed, Inc.
Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3
Open, Classified
DYBK192769

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