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)
Top companies in DYB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 20 | 67 |
| Terumo Medical Corp. | 27 | 29 |
| Merit Medical Systems | 19 | 35 |
| Oscor, Inc. | 13 | 37 |
| ARROW INTERNATIONAL, LLC | 0 | 37 |
| Abiomed, Inc. | 6 | 28 |
| Thomas Medical Products, Inc. | 17 | 15 |
| St Jude Medical | 26 | 3 |
| Cordis Corp. | 22 | 3 |
| Boston Scientific | 16 | 6 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 10, 2026 | Terumo 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 |
DYB | K173831 |
| Jul 10, 2026 | Abiomed, 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 |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, 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 |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, 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 |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, Inc. ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories Open, Classified |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, 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 |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, 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 |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, 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 |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, 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 |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, 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 |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, 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 |
DYB | K192769 K201116 |
| Jul 10, 2026 | Oscor Inc. Abiomed REF: 0052-3006, Introducer Kit for Impella
Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories. Open, Classified |
DYB | K122084 |
| Jul 10, 2026 | Oscor 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 |
DYB | K122084 |
| Jul 10, 2026 | Oscor 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 |
DYB | K122084 |
| Jul 10, 2026 | Abiomed, 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 |
DYB | K192769 K201116 |
| Jul 10, 2026 | Abiomed, 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 |
DYB | K192769 K201116 |
| Jun 25, 2026 | Abiomed, 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 |
DYB | K241708 |
| Jun 25, 2026 | Abiomed, Inc. Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834. Open, Classified |
DYB | K241708 |
| Jun 25, 2026 | Abiomed, 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 |
DYB | K241708 |
| Jun 25, 2026 | Abiomed, 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 |
DYB | K241708 |
| Jun 13, 2026 | ARROW 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 |
DYB | K002507 K011761 +2 |
| May 15, 2026 | Becton, 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 |
DYB | K231248 K233824 |
| Mar 26, 2026 | Merit Medical Systems, Inc. 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B Open, Classified |
DYB | K043438 |
| Dec 23, 2025 | Cook 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 |
DYB | K171820 |
| Dec 23, 2025 | Cook 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 |
DYB | K171820 |
| Dec 23, 2025 | Cook 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 |
DYB | K142829 |
| Sep 5, 2025 | Contract 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 |
DYB | K153197 |
| May 16, 2025 | Cook 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 |
DYB | None listed |
| May 16, 2025 | Cook 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 |
DYB | K171999 |
| May 7, 2025 | Galt 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 |
DYB | K043525 |
| Mar 24, 2025 | Merit Medical Systems, Inc. Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D Open, Classified |
DYB | K173750 |
| Jan 29, 2025 | MEDLINE INDUSTRIES, LP - Northfield CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating. Open, Classified |
DYB | K885179 |
| Oct 9, 2024 | Cook 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 |
DYB | K171999 |
| Aug 12, 2024 | Merit 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 |
DYB | K120158 |
| Aug 12, 2024 | Merit 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 |
DYB | K152381 |
| Aug 12, 2024 | Merit 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 |
DYB | K143255 |
| Aug 12, 2024 | Merit 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 |
DYB | K172117 |
| Aug 12, 2024 | Merit 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 |
DYB | K120158 |
| Jul 12, 2024 | St. Jude Medical St. Jude Medical Agilis NxT Steerable Introducer, REF 408309 Open, Classified |
DYB | K061363 |
| Jun 27, 2024 | Merit 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 |
DYB | K211405 |
| May 20, 2024 | Merit Medical Systems, Inc. Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY Open, Classified |
DYB | K211405 |
| May 20, 2024 | Merit Medical Systems, Inc. Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY Open, Classified |
DYB | K211405 |
| Apr 12, 2024 | Cook 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 |
DYB | None listed |
| Mar 28, 2024 | Boston Scientific Corporation Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system Open, Classified |
DYB | K180785 K191871 +2 |
| Mar 13, 2024 | Biosense 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 |
DYB | K170997 |
| Jan 5, 2024 | Abiomed, 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 |
DYB | None listed |
| Jan 5, 2024 | Abiomed, 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 |
DYB | None listed |
| Jan 5, 2024 | Abiomed, 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 |
DYB | None listed |
| Jan 5, 2024 | Abiomed, 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 |
DYB | K192769 |
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