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 22, 2013 | Merit Medical Systems, Inc. Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3. Terminated |
DQO | K943739 |
| May 25, 2013 | Merit Medical Systems, Inc. Merit Medical PerfOrma Anglographic Catheter 5F Multipack
Product Usage:
Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in con Terminated |
DQO | K943739 |
| Oct 11, 2012 | ICU Medical, Inc. 3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and
DyePod, Part Number (Item #) AG8049-NS, Lot # 2528655.
K914299.
Waste system. Terminated |
DQO | K914299 |
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J.
For use in patients who require hemodynamic monitoring. Terminated |
DQO | K915726 |
| Aug 12, 2012 | Edwards Lifesciences, LLC Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7.
For use in patients who require hemodynamic monitoring. Terminated |
DQO | K915726 |
| Aug 9, 2012 | Angiodynamics Worldwide Headquarters AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheter Terminated |
DQO | K061733 |
| Aug 2, 2012 | ICU Medical, Inc. Flush Kit w 3 Way Off Stopcock
Product Usage:
Flush Kit Terminated |
DQO | K052865 |
| Aug 2, 2012 | ICU Medical, Inc. Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets
Product Usage:
For waste managment. Terminated |
DQO | K052865 |
| Aug 2, 2012 | ICU Medical, Inc. High Pressure Stopcock (3-Way, Luer Lock, Off).
Product Usage:
For IV. Terminated |
DQO | K052865 |
| Apr 11, 2012 | Boston Scientific Corporation Boston Scientific, IMAGER II Angiographic Catheter, Sterilized with ethylene oxide gas. Made in Ireland, Manufactured for Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1 Terminated |
DQO | K011664 K022621 +1 |
| Nov 17, 2011 | Cordis Corporation SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN end***Sidehole Terminated |
DQO | K992347 |
| Nov 17, 2011 | Cordis Corporation SUPER TORQUE MB Angiographic Catheter product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97 mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic Catheter** Terminated |
DQO | K992347 |
| Sep 16, 2011 | Angiodynamics Worldwide Headquarters ANGIODYNAMICS Angiographic Catheter, Soft-Vu Cobra (2) BRAIDED, 5 F x 90 cm x .035 in., Catalog No./REF 10709105, STERILE, MANUFACTURED IN USA, AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, Terminated |
DQO | K061733 |
| Jul 11, 2011 | Vascular Solutions, Inc. Langston Dual Lumen Catheters, REF 5515, 7F, Sterile EO, Rx ONLY, 1 x Catheter and 5 x Catheter, Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369.
Langston dual lumen catheters a Terminated |
DQO | K061565 |
| Jun 10, 2011 | Boston Scientific Corporation Boston Scientific, Atlantis SR Pro 2, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, USE BY 2011-05, REF 39014, UPN H749390140, Sterile R Sterilized using irradiation, Made in USA 47900 Ba Terminated |
DQO | K050577 K063312 |
| Jun 10, 2011 | Boston Scientific Corporation Boston Scientific iCross, 40 MHz Coronary Imaging Catheter, 3.6F (1.18mm) x 135 cm, REF / Catalog No. 51805, UPN / Product No. H749518050, Sterilized using irradiation, Made in USA 47900 Bayside Park Terminated |
DQO | K050577 K063312 |
| Mar 24, 2011 | Millar Instruments, Inc Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters Sterile and Nonpyrogenic Model SPC-454D and SPC454F.
Provide intravascular pressure readings and capabilit Terminated |
DQO | K952773 K993694 |
| Mar 23, 2011 | Siemens Medical Solutions USA, Inc. Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors;
Model Number: 10348560. Terminated |
DQO | K033650 K071234 +1 |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | K913682 |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-10573, Manufactured by Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | K913682 |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09815, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | K913682 |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision B, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | K913682 |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09689, Revision A, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | K913682 |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09304, Revision B, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | K913682 |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872P, Revision H, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | K913682 |
| Dec 8, 2010 | Merit Medical Systems, Inc. Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872 Revision H, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA, Terminated |
DQO | K913682 |
| Nov 17, 2010 | Millar Instruments, Inc Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, Inc 6001-A Gulf Freeway, Houston, Texas 77023 Terminated |
DQO | K952773 K993694 |
| Sep 28, 2010 | Vascular Solutions, Inc. Langston Dual Lumen Catheters, 6F, REF 5540, Sterile EO, RX only, Vascular Solutions, Inc, 6464 Sycamore Court, Minneapolis, MN 55369, 110 cm length, - 0.038" recom guidewire, 1000 psi pressure limit. Terminated |
DQO | K051395 |
| May 28, 2010 | Merit Medical Systems, Inc. Vessel Sizing Angiographic Catheter, REF 7602-2M65, 5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095.
Designed to be used for delivering radiopa Terminated |
DQO | K000659 |
| Jan 21, 2010 | Boston Scientific Corporation Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas, Manufactured for Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, USA, Made in Ireland, Unit 7, Terminated |
DQO | K050863 |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Connection tubes label reading in part: CONNECTING TUBE W/ STOPCOCK 12" CATALOG NUMBER K10-04131 LOT F720653 Connection tubing can be used with any drainage catheter and d Terminated |
DQO | K913682 |
| Dec 14, 2009 | Merit Medical Systems, Inc. Merit Medical Systems, Inc. Connection Tube label reading in part: CONNECTING TUBE 12" STERILE K10-04129, CATALOG NUMBER K10-04129 Connection tubing can be used with any drainage catheter and drainag Terminated |
DQO | K913682 |
| Sep 4, 2009 | Boston Scientific Corporation Boston Scientific Expo, Angiographic Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Mesa, Edificion G1, Suites B. H, Tijuana, Baja California 22650 MEX.
Boston Sci Terminated |
DQO | K934541 K934581 |
| Sep 4, 2009 | Boston Scientific Corporation Boston Scientific Impulse Flextrusion Shaft, Angiographic Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Mesa, Edificion G1, Suites B. H, Tijuana, Baja California 2 Terminated |
DQO | K964859 |
| Sep 4, 2009 | Boston Scientific Corporation Boston Scientific Wiseguide, Guide Catheter, Sterilized with ethylene oxide gas, Made in Mexico, Parque Industrial La Mesa, Edificion G1, Suites B. H, Tijuana, Baja California 22650 MEX.
Boston Scien Terminated |
DQO | K970823 K974684 +1 |
| Jan 13, 2009 | Merit Medical Systems, Inc. Custom Waste Management Kit, K10-01756/B, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Terminated |
DQO | K913682 |
| Sep 4, 2008 | Merit Medical Systems, Inc. Custom Kit, REF: K05-00843, Revision L, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
DQO | None listed |
| Sep 4, 2008 | Merit Medical Systems, Inc. Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
DQO | None listed |
| Sep 4, 2008 | Merit Medical Systems, Inc. Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems, Inc., South Jordan, Utah 84095. Terminated |
DQO | None listed |
| Jan 31, 2008 | Boston Scientific Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-03. 6F FR5 ( Terminated |
DQO | None listed |
| Jan 31, 2008 | Boston Scientific Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-01. 6F FR3.5 Terminated |
DQO | None listed |
| Jan 31, 2008 | Boston Scientific Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-98. 6F AL2 ( Terminated |
DQO | None listed |
| Jan 31, 2008 | Boston Scientific Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-302. 6F MULT Terminated |
DQO | None listed |
| Jan 31, 2008 | Boston Scientific Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-201. 6F IM ( Terminated |
DQO | None listed |
| Jan 31, 2008 | Boston Scientific Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-86. 6F AR2 ( Terminated |
DQO | None listed |
| Jan 31, 2008 | Boston Scientific Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-202. 6F IM Terminated |
DQO | None listed |
| Jan 31, 2008 | Boston Scientific Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-195. 6F LCB Terminated |
DQO | None listed |
| Jan 31, 2008 | Boston Scientific Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-04. 6F FR6 Terminated |
DQO | None listed |
| Jan 31, 2008 | Boston Scientific Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-89. 6F AR MO Terminated |
DQO | None listed |
| Jan 31, 2008 | Boston Scientific Boston Scientific, Impulse Angiographic Catheter, Sterile EO. Catheters are single lumen catheters with a single proximal hub for attachment to a dye delivery system. Catalog No. 16599-301. 6F MULT Terminated |
DQO | K000956 K964859 +2 |
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