Panels › Cardiovascular › Product code DQO · Class 2
Catheter, Intravascular, Diagnostic
Regulation 870.1200
3510(k)s in 12 months (501 all time)
26recalls in 12 months (285 all time)
246recalls that name a 510(k)
Top companies in DQO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 15 | 85 |
| Boston Scientific Corp | 20 | 73 |
| Merit Medical Systems, Inc. | 8 | 33 |
| Cordis Corp. | 29 | 8 |
| AngioDynamics, Inc. | 11 | 23 |
| Vascular Solutions, Inc. | 12 | 10 |
| C.R. Bard, Inc. | 16 | 0 |
| Scimed Life Systems, Inc. | 16 | 0 |
| LeMaitre Vascular, Inc. | 0 | 12 |
| Target Therapeutics | 10 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 21, 2019 | Cook Inc. Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and exper Terminated |
DQO | K133130 |
| Oct 17, 2018 | Numed Inc Multi-Track Angiographic Catheter (MMTA)
Product Code: MMTA06100
Product Usage:
Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for i Terminated |
DQO | K952984 |
| Oct 17, 2018 | Numed Inc Multi-Track Angiographic Catheter (MMTA)
Product Code: MMTA05100
Product Usage:
Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for i Terminated |
DQO | K952984 |
| Aug 16, 2018 | Medtronic Vascular Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35 Terminated |
DQO | K161287 |
| Apr 20, 2018 | Medtronic Vascular Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box. Terminated |
DQO | K161287 |
| Feb 13, 2018 | Angiodynamics, Inc. Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201
AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is in Terminated |
DQO | K112452 |
| Jun 27, 2017 | Boston Scientific Corporation Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inn Terminated |
DQO | K121694 |
| Mar 23, 2017 | Boston Scientific Corporation Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN) Terminated |
DQO | K121694 |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter with Introducer (paper IFU)
REF# 2401-53 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU)
REF# e2401-53 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (paper IFU)
REF# 2401-52 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Scoop Tip Cholangiogram Catheter with Introducer (eIFU)
REF# e2401-52 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (paper IFU)
REF# 2401-51 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter with Introducer (eIFU)
REF# e2401-51 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Scoop Tip Cholangiogram Stiffer Catheter (paper IFU)
REF# 2401-50 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Scoop Tip Cholangiogram Catheter (eIFU)
REF# e2401-50 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter with introducer (eIFU)
REF # e2400-53 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Cholangiogram Catheter with introducer(eIFU)
REF # e2400-52 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Cholangiogram Stiffer Catheter (eIFU)
REF# e2400-51 Terminated |
DQO | None listed |
| Feb 7, 2017 | LeMaitre Vascular, Inc. LeMaitre Vascular Reddick Cholangiogram Catheter (eIFU)
REF# e2400-50 Terminated |
DQO | None listed |
| Jan 12, 2017 | Vascular Solutions, Inc. GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide.
Product Usage:
The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the va Terminated |
DQO | K081846 |
| Oct 20, 2016 | Vascular Solutions, Inc. Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide.
The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and Terminated |
DQO | K062877 |
| Sep 2, 2016 | Arrow International Inc HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, ena Terminated |
DQO | K895268 |
| Aug 22, 2016 | Cook Inc. Slip-Cath Beacon Tip Catheter
Catheter, Intravascular, Diagnostic
The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Terminated |
DQO | K122937 |
| Aug 22, 2016 | Cook Inc. Shuttle Select Slip-Cath
Catheter, Intravascular, Diagnostic
The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques Terminated |
DQO | K122937 |
| Aug 22, 2016 | Cook Inc. Beacon Tip Centimeter Sizing Catheter
Beacon Tip White Vessel Sizing Catheter
Beacon Tip Vessel Sizing Catheter
Catheter, Intravascular, Diagnostic
The catheters are intended for use in angiographic Terminated |
DQO | None listed |
| Aug 22, 2016 | Cook Inc. Beacon Tip Royal Flush Plus High-Flow Catheter
Catheter, Intravascular, Diagnostic
The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic t Terminated |
DQO | None listed |
| Aug 22, 2016 | Cook Inc. Beacon Tip Torcon NB Advantage Catheter
Catheter, Intravascular, Diagnostic Terminated |
DQO | K133130 |
| Jul 22, 2016 | Stryker Sustainability Solutions AngioDynamics Soft Vu Omni Flush Angiographic Catheter
Model Number: 10732203 Terminated |
DQO | K001578 |
| May 20, 2016 | B. Braun Medical, Inc. WHIN Infusion Set - 90 Huber Needle and Wing (22 ga/1in). Intravenous delivery through intravascular ports, 20 units per case, Catalog Number 471734.
Usage: Infusion of solution/medication into impla Terminated |
DQO | K760388 |
| Feb 24, 2016 | Cook Inc. Shuttle Select Slip-Cath Catheter. Angiographic catheter.
For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. T Terminated |
DQO | K122937 |
| Aug 5, 2015 | Cook Inc. Slip-Cath Beacon Tip Catheter. Angiographic catheter.
For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The Terminated |
DQO | K122937 |
| Aug 5, 2015 | Cook Inc. Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter.
For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion Terminated |
DQO | None listed |
| Aug 5, 2015 | Cook Inc. Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or ste Terminated |
DQO | K133130 |
| Sep 12, 2014 | Volcano Corporation Volcano TrakBack II Disposable Pullback Device;
Sterile and nonpyrogenic; Single Use.
TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data. Terminated |
DQO | K003938 |
| Jul 3, 2014 | Vascular Solutions, Inc. Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast m Terminated |
DQO | K051395 |
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