Company
Medtronic Inc. Cardiac Rhythm Disease Management
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
37recalls (0 in 12 months)
29recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 14 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 3 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 3 |
| DQX | Wire, Guide, Catheter | 2 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 2 |
| DYB | Introducer, Catheter | 2 |
| DQY | Catheter, Percutaneous | 1 |
| DRA | Catheter, Steerable | 1 |
| DTB | Permanent Pacemaker Electrode | 1 |
| DTE | Pulse-Generator, Pacemaker, External | 1 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 1 |
| KRA | Catheter, Continuous Flush | 1 |
| LPB | Cardiac Ablation Percutaneous Catheter | 1 |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | 1 |
| NKE | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | 1 |
| NVZ | Pulse Generator, Permanent, Implantable | 1 |
| OAE | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2015 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. Th Terminated |
DTB | K883743 K932172 +1 |
| Sep 17, 2015 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K
For use in performing cardiac ablation procedures. Terminated |
LPB | None listed |
| Apr 2, 2015 | Medtronic Inc. Cardiac Rhythm Disease Management Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, Terminated |
KRA | K071664 K130904 |
| Mar 31, 2015 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Dual Chamber Temporary External Pacemaker, Model 5392.
Product Usage:
The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a cl Terminated |
DTE | K132924 K150246 |
| Mar 17, 2015 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065.
The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of t Terminated |
DYB | K142684 |
| May 24, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI).
Used in conjunction with a cardiac pacing lead system for temporary atrial or Terminated |
LWP | None listed |
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Intersept Custom Tubing Pack which contain Select 3D or Select CAP Arterial Cannulae. Model 3Y90R3, the following model is only approved in Europe C300901B. Sterilized using Ethylene Oxide Terminated |
DWE | K800178 |
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic.
The Select 3D Arterial Cannulae has clear flexible, th Terminated |
DWF | K033416 |
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.), 78922 (22 Fr.), 78924 (24 Fr.). Sterilized using E Terminated |
DWF | K010737 |
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select 3D Arterial Cannulae. Vented, model 78624 (24 Fr.). Non-Vented Cannulae, model 78724 (24 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic.
The Cannula consists of a curved Terminated |
DWF | K000776 |
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select 3D Arterial Cannulae. Vented, model 78622 (22 Fr.). Non-Vented Cannulae, model 78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic.
The Cannula consists of a curved Terminated |
DWF | K013013 |
| Feb 20, 2014 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyroge Terminated |
DWF | K043179 |
| Aug 27, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Custom Perfusion System with Trillium BioSurface (a polymer containing non-leaching heparin). Model Numbers: TL4X17R8, TL5D01R, TL5D02R, TL5D02R3, TL5D02R5, and TL6A65R7.
Sterilized by E Terminated |
DWF | K012538 |
| Aug 27, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7.
Sterilized by Ethylene Oxide, Do no Reuse.
Product Usage: Usage:
This product is indica Terminated |
DTZ | K891687 |
| Aug 27, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Custom Perfusion System. Model Numbers: 1D80R8, 1E34R1, 1F75R1, 1G49R2, 1G75R1, 1P07R8, 1P91R4, 5B15R11, and 5P51R9.
Sterilized by Ethylene Oxide, Do no Reuse.
Product Usage:
This pr Terminated |
DWE | K800178 |
| Aug 14, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide.
Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile E Terminated |
DTM | K071253 |
| Aug 5, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Mullins Transseptal Adult 7F, REF 008551.
Intended for the introduction of cardiovascular catheters into the left side of the heart. Terminated |
DYB | K791963 |
| Jun 27, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, Consulta CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra CRT-P, Model C2TR01, Sterile EO.
Dual chamber and atrial tracking modes are indicated for patients who may benefi Terminated |
NKE | None listed |
| Jun 21, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F
Product Usage: The Medtronic Guiding Catheter is designed to provide a pathw Terminated |
DQY | K021256 K103386 |
| Mar 28, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide.
Product Usage:
The Medtronic Archer 0.035 inch (0.89mm) Super Terminated |
DQX | K101339 |
| Mar 28, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W.
Intended to facilitate catheter placement and exchange during procedures in the aorta. Terminated |
DQX | K101339 |
| Mar 5, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures.
Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318 Terminated |
DWF | K120988 K842375 |
| Dec 28, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers:
Terminated |
DWF | K012538 K113845 +2 |
| Mar 22, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153DRG and D154DRG. The implantable cardioverter defibrillator is intended to provide ventr Terminated |
LWS | None listed |
| Mar 22, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic EnTrust, Single Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153VRC and D154VRC. The implantable cardioverter defibrillator is intended to provide ven Terminated |
LWS | None listed |
| Mar 22, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Atrial and Ventricular Therapies, models D153ATG and D154ATG. The device is indicated for use in ICD patients with atrial Terminated |
LWS | None listed |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Custom Packs/ Kerkrade.
Contain Medtronic Venous Cannula, Sterile EO.
Model #'s
C330201C, C330201D, C330201E, C330206B, C342603A, C350106A, C390101D, C390203D, C390406C, C390409B, C390601C, C390601 Terminated |
DWE | K800178 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Custom Packs/Mexico,
Medtronic Cardio-Kit, Sterilized Using Ethylene Oxide, Nonpyrogenic, Rx Only. Model #
DLP6N48R3 & DLP6N48R4.
Medtronic Intersept Custom Tubing Pack with Trillium Biosurface, Terminated |
DTZ | K891687 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, Single Stage Venous Cannula, Carmeda Bio-Active Surface Venous Cannula, Sterilized Using Ethylene Oxide, Rx Only, Nonpyrogenic.
Model # 's
CB66112, CB66114, CB66116, CB66118, CB66120, C Terminated |
DWF | K022272 K842375 +1 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, DLP, DLP Malleable Single Stage Venous CannulaeRx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic.
Model # 91037.
These cannulae are intended for collection of venous blood from the Terminated |
DWF | K854487 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, DLP, DLP Malleable Single Stage Venous Cannulae.
Rx Only, Sterilized Using Ethylene Oxide, Nonpyrogenic. Model #'s
68112, 68114, 68116, 68118, 68120, 68122, 68124, 68126, 68128, 68130, 6 Terminated |
DWF | K022272 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, DLP, DLP Right Angle Single Stage Venous Cannulae.
Rx Only, Sterile EO, Nonpyrogenic. Model #'s
67512, 67514, 67516, 67518, 67520, 67522, 67524, 67526, 67528, 67530, 67532, 67534, 67636. Terminated |
DWF | K842375 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic DLP, DLP Single Stage Venous Cannulae.
Rx Only, Sterile EO, Nonpyrogenic. Model #'s
66112, 66114, 66116, 66118, 66120, 66122, 66124, 66126, 66128, 66130, 66132, 66134, 66236, 66238, 66240 Terminated |
DWF | K845045 |
| Jan 18, 2012 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic DLP, DLP Single Stage Venous Cannula w/Right Angle Metal Tip.
Rx Only, Sterile EO, Nonpyrogenic. Model number #'s :
67312, 67314, 67316, 67318, 67320, 69312, 69314, 69316, 69318, 68320, Terminated |
DWF | K842375 |
| Nov 2, 2011 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, Model 2AF282 and 2AF231 ( not distributed in US)
Product Usage: The Medtronic CryoCath System Terminated |
OAE | None listed |
| Sep 12, 2011 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic FlexCath, model 3FC12, Steerable Sheath. The FlexCath Steerable Sheath is a percutaneous catheter introducer fitted with a valve to allow for introduction, withdrawal, and swapping of cathe Terminated |
DRA | K102176 |
| Apr 29, 2011 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic, Kappa 600
KDR600,KDR601,KDR603,KDR606,KDR651,KDR653
The devices are implantable pulse generators (IPG) used to detect bradycardia events and provide pacing support. Within each product fam Terminated |
NVZ | None listed |