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) |
|---|---|---|---|
| Mar 18, 2005 | Becton Dickinson Infusion Therapy BD Exacta 6Fr Percutaneous Sheath Introducer Tray. Terminated |
DYB | K941428 |
| Mar 18, 2005 | Becton Dickinson Infusion Therapy BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray Terminated |
DYB | K941428 |
| Oct 28, 2004 | Thomas Medical Products Inc SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1011. The product is shipped in cartons containing 5 units Terminated |
DYB | None listed |
| Oct 28, 2004 | Thomas Medical Products Inc SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1009. The product is shipped in cartons containing 5 units. Terminated |
DYB | None listed |
| Oct 28, 2004 | Thomas Medical Products Inc SafeSheath KR under the Pressure Products label. Tearaway KR Kit. Catalog number HLS/KR-1007. The product is shipped in cartons containing 5 units Terminated |
DYB | K934901 |
| Sep 1, 2004 | St. Jude Medical/Daig Division Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Left Lateral Reorder #407901. The product is packaged in an open, semi-r Terminated |
DYB | K964518 K973840 +1 |
| Sep 1, 2004 | St. Jude Medical/Daig Division Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. The product is packaged in an open, semi Terminated |
DYB | K964518 K973840 +1 |
| Jul 20, 2004 | Thomas Medical Products Inc SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD; CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG (Coronary Sinus Guide)-2-09 Jumbo; CSG (Coronary Sinus Guide)/BCor/-2-09; CSG (Coronary Sinus Terminated |
DYB | None listed |
| Jul 20, 2004 | Thomas Medical Products Inc SafeSheath CSG (Coronary Sheath Guide) Multisite (MSP)-00-6.5 and CSG (Coronary Sheath Guide) Multisite-00.09 Terminated |
DYB | None listed |
| Jul 20, 2004 | Thomas Medical Products Inc SafeSheath CSG (Coronary Sinus Guide) KR-90.09 and CSG (Coronary Sinus Guide) KR/BCor-90.09. These sheaths are packaged in 5 individual boxed kits per case carton. Terminated |
DYB | None listed |
| Jul 20, 2004 | Thomas Medical Products Inc Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG (Coronary Sinus Guide)/BCor-90/09. These sheaths packaged in 5 individual boxed kits per case carton. Terminated |
DYB | None listed |
| Jul 20, 2004 | Deltec, Inc 8.5 Fr Introducer Set, REF 21-2370-24 Terminated |
DYB | K954015 |
| Jul 20, 2004 | Deltec, Inc 9 Fr Introducer Set, REF 21-2340-24 Terminated |
DYB | K954015 |
| Jul 20, 2004 | Deltec, Inc 6 Fr Introducer Set, REF 21-2320-24 Terminated |
DYB | K954015 |
| Jul 20, 2004 | Arrow International Inc Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr.
Introducer Kit Implantable Vascular Access System (Product # AP-06022) [NB:
plastic port]
Product # AP-06022 kit contains 1 lo Terminated |
DYB | K921475 K933316 +2 |
| Jul 20, 2004 | Arrow International Inc Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable (Product # AP-06042) [NB: titanium port].
Product # AP-06042 kit contains 1 low profile implantable t Terminated |
DYB | K921475 K933316 +2 |
| Jul 20, 2004 | Arrow International Inc Arrow A Port with Attachable Silicone Rubber Catheters Implantable Vascular Access System (Product # AP-01510) .
Product # AP-01510 kit contains 1 implantable titanium port, 2 attachable silicone rubb Terminated |
DYB | K921475 K933316 +2 |
| Jul 20, 2004 | Arrow International Inc Arrow A Port with Attachable Silicone Rubber Catheters/10 Fr.
Introducer Kit Implantable Vascular Access System (Product # AP-06520)
Product # AP-06520 kit contains 1 implantable titanium port, 2 att Terminated |
DYB | K921475 K933316 +2 |
| Jul 2, 2003 | MedAmicus,Inc Bulk 16 FR Valved PTFE Sheath/Dilator, Part Number 10614-011 Terminated |
DYB | K021044 |
| Jul 2, 2003 | MedAmicus,Inc Medamicus FlowGuard 16 FR Valved Peelable Venous Introducer, 5 units per shelf box, Part Number 10684-003 Terminated |
DYB | K021044 |
| Jul 2, 2003 | MedAmicus,Inc AngioDynamics 16F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507603 Terminated |
DYB | K021044 |
| Jul 2, 2003 | MedAmicus,Inc AngioDynamics 15F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507602 Terminated |
DYB | K021044 |
| Jul 2, 2003 | MedAmicus,Inc AngioDynamics 14F EmboSafe Valved Peelable Introducer, 5 units per shelf box, Catalog number 06507601 Terminated |
DYB | K021044 |
| Jul 2, 2003 | MedAmicus,Inc Medamicus FlowGuard 15FR Valved Peelable Introducer Kit, Catalog Number 10532-010 Terminated |
DYB | K021044 |
| Jul 2, 2003 | MedAmicus,Inc Medamicus FlowGuard 16 FR Valved Peelable Introducer Kit, Catalog Number 10532-011 Terminated |
DYB | K021044 |
| Jun 12, 2003 | Cordis Corporation Product is Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 9, 10 and 11French sizes only). Terminated |
DYB | K954595 K971608 +1 |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-15.0-SC-NT-MKDT-090600 Terminated |
DYB | None listed |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-15.0-SC-NT Terminated |
DYB | None listed |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-15.0-SC Terminated |
DYB | None listed |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-10.0-SC-U Terminated |
DYB | None listed |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-10.0-SC-NT-U Terminated |
DYB | None listed |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-10.0-SC-NT Terminated |
DYB | None listed |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-10.0-SC-LONDON-062593 Terminated |
DYB | None listed |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 5 FR.
Product Reorder Number: MPIS-501-10.0-SC Terminated |
DYB | None listed |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 4 FR.
Product Reorder Number: MPIS-401-20.0-SC-UA-082900 Terminated |
DYB | None listed |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 4 FR.
Product Reorder Number: MPIS-401-15.0-SC-NT Terminated |
DYB | None listed |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 4 FR.
Product Reorder Number: MPIS-401-10.0-SC-NT-U Terminated |
DYB | None listed |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 4 FR.
Product Reorder Number: MPIS-401-10.0-SC-NT Terminated |
DYB | None listed |
| Feb 28, 2003 | Cook, Inc. COOK Stiffened Micropuncture Introducer Set, 4 FR.
Product Reorder Number: MPIS-401-10.0-SC Terminated |
DYB | None listed |
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