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) |
|---|---|---|---|
| Dec 6, 2007 | Boston Scientific Corporation Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-508, Lot 48951, Description 5 Fr Flush TR, Sterile EO, Made in Ireland, Unit 7, Terminated |
DQO | K011664 K050863 |
| Aug 9, 2007 | Boston Scientific Corporation Boston Scientific Impulse Flextrusion Shaft 5F FL4 16391-22 H74916391222, (5-Pack Carton Label), Angiographic Catheters.
Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, B Terminated |
DQO | None listed |
| Aug 9, 2007 | Boston Scientific Corporation Boston Scientific Impulse Flextrusion Shaft 5F FR4 16391-02 H74916391022, (5-Pack Carton Label), Angiographic Catheters.
Made in Mexico Parque Industrial La Mesa Edificio G1, Suites B, H Tijuana, B Terminated |
DQO | K964859 |
| Feb 1, 2007 | Boston Scientific Target Boston Scientific brand iLab Ultrasound Imaging System, for intravascular use;
Model Number(s): iLab120lNS, iLab2401NS,
Distributed by and Manufactured by:
Boston Scientific Corporation IVUS, Tech Terminated |
DQO | K051679 |
| Jul 13, 2006 | Cordis Corporation Cordis INFINITI 6 French Diagnostic Catheter. Catalog 534-6xxT. That is:
534614T, 534615T, 534617T, 534618T, 534619T, 534620T, 534621T, 534622T, 534623T, 534624T, 534625T, 534627T, 534628T, 534629T, Terminated |
DQO | K911310 K960975 +1 |
| Apr 22, 2006 | Boston Scientific Target iLab Utrasound Imaging System, software controlled Imaging Catheter. Terminated |
DQO | K051679 |
| Oct 21, 2005 | Merit Medical Systems, Inc Merit Custom Procedure Kit Terminated |
DQO | K913682 |
| Oct 21, 2005 | Merit Medical Systems, Inc Merit Custom Procedure Kit Terminated |
DQO | K913682 |
| Oct 21, 2005 | Merit Medical Systems, Inc Merit Custom Procedure Kit Terminated |
DQO | K913682 |
| Oct 21, 2005 | Merit Medical Systems, Inc Merit Custom Procedure Kit Terminated |
DQO | K913682 |
| Oct 21, 2005 | Merit Medical Systems, Inc Merit Custom Procedure Kit Terminated |
DQO | K913682 |
| Oct 15, 2005 | Origen Biomedical, Inc Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744 Terminated |
DQO | None listed |
| Mar 18, 2005 | Millar Instruments, Inc Mikro-Tip Disposable Angiographic Catheter manufactured by Millar Instruments, Houston, Texas Terminated |
DQO | K993694 |
| Mar 15, 2005 | Hospira Inc. Catheterization Kits containing Angiographic Syringes with rotator connector. Terminated |
DQO | K932141 |
| Mar 15, 2005 | Hospira Inc. Angiographic Syringe, 12 cc Palm Pad with Rotator Reservoir. Terminated |
DQO | K884823 K932188 +2 |
| Mar 15, 2005 | Hospira Inc. Angiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir. Terminated |
DQO | K884823 K932188 +2 |
| Mar 15, 2005 | Hospira Inc. Angiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir. Terminated |
DQO | K884823 K932188 +2 |
| Mar 15, 2005 | Hospira Inc. Angiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir. Terminated |
DQO | K884823 K932188 +2 |
| Nov 16, 2004 | Medex Inc MX20170: Pediatric 40 In Sampling Kit w/10cc syringe,
MX20443: LogiCal Single Pressure Kit,
MX20470: Pressure Monitoring Kit,
MX20477: LogiCal Double Kit,
MX20730: Double LogiCal Kit,
MX20760: Neonata Terminated |
DQO | K902771 |
| Nov 11, 2004 | Merit Medical Systems, Inc Custom Convenience Kit Terminated |
DQO | None listed |
| Oct 28, 2004 | Merit Medical Systems, Inc Convenience Kits containing Inject8 or Inject10 syringes. Terminated |
DQO | None listed |
| Jul 20, 2004 | Boston Scientific Scimed Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011 Terminated |
DQO | None listed |
| Feb 10, 2004 | Medtronic, Inc. Medtronic SiteSeer 5 F Tight Radius 145 Pigtail
Cardiovascular Angiographic Catheter
Item Number: 5A0029 Terminated |
DQO | K932092 |
| Nov 27, 2003 | Merit Medical Systems, Inc UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, Merit Medical. Terminated |
DQO | K943739 |
| Nov 27, 2003 | Merit Medical Systems, Inc UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medical. Terminated |
DQO | K943739 |
| Nov 19, 2003 | Merit Medical Systems, Inc Waste Collection Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part # K10-01047. Terminated |
DQO | None listed |
| Nov 19, 2003 | Merit Medical Systems, Inc Manifold Custom Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part # K09-07862B, # K09-07873, #K09-02498F, #K09-07828b, #K09-009 Terminated |
DQO | None listed |
| Nov 19, 2003 | Merit Medical Systems, Inc Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, Terminated |
DQO | None listed |
| Jun 5, 2003 | Merit Medical Systems, Inc Custom Kit Terminated |
DQO | None listed |
| May 20, 2003 | Vygon Corporation Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. catheter and a separately packaged catheter tray. The catheter tray and its respec Terminated |
DQO | K954112 |
| May 20, 2003 | Vygon Corporation Nutriline with Peelable Sheath 2 Fr. is a 2 Fr. peripherally inserted catheter (PIC). Included with this catheter is a 2 Fr. insertion sheath. Product is packaged in tyvek sealed plastic tray. Ster Terminated |
DQO | K954112 |
| Mar 20, 2003 | Curon Medical Inc Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K Terminated |
DQO | None listed |
| Mar 6, 2003 | Merit Medical Systems, Inc Custom Angiographic Kit Terminated |
DQO | K883718 K913682 +2 |
| Mar 6, 2003 | Merit Medical Systems, Inc Custom Angiographic Kit Terminated |
DQO | K883718 K913682 +2 |
| Mar 6, 2003 | Merit Medical Systems, Inc Custom Angiographic Kit. Terminated |
DQO | K883718 K913682 +2 |
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