Product code LKK ยท Class 3
Pump, Infusion, Implanted, Programmable
0510(k)s in 12 months (0 all time)
2recalls in 12 months (132 all time)
1recalls that name a 510(k)
Top companies in LKK
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Neuromodulation | 0 | 96 |
| Codman & Shurtleff, Inc. | 0 | 13 |
| Flowonix Medical Inc | 0 | 13 |
| Medtronic Inc, Neurological & Spinal Division | 0 | 3 |
| Medtronic Inc. | 0 | 2 |
| Medtronic Neurological | 0 | 2 |
| Boston Scientific Corporation | 0 | 1 |
| Intera Oncology, Inc. | 0 | 1 |
| Smiths Medical ASD Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2013 | Codman & Shurtleff, Inc. MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine
Product Code:
91-4201US (40ml pump)
91-4201 (40ml pump)
Intended for the intrathecal delivery o Terminated |
LKK | None listed |
| Jul 16, 2013 | Codman & Shurtleff, Inc. MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine
Product Code:91-4200 (20ml pump) US 91-4200.
Intended for the intrathecal delivery of Baclofen o Terminated |
LKK | None listed |
| Jun 25, 2013 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. The pump is part Terminated |
LKK | None listed |
| Jun 25, 2013 | Medtronic Neuromodulation Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and deli Terminated |
LKK | None listed |
| Jun 25, 2013 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide.
Product Usage Terminated |
LKK | None listed |
| Jun 25, 2013 | Medtronic Neuromodulation Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide.
Product Usage:
The pump is part of an infusion system Terminated |
LKK | None listed |
| Jun 24, 2013 | Medtronic Neuromodulation Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeve Terminated |
LKK | None listed |
| Jun 24, 2013 | Medtronic Neuromodulation Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump connector with attached 7.6-cm ca Terminated |
LKK | None listed |
| Jun 24, 2013 | Medtronic Neuromodulation Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strai Terminated |
LKK | None listed |
| Jun 24, 2013 | Medtronic Neuromodulation Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Terminated |
LKK | None listed |
| Dec 13, 2012 | Medtronic Neuromodulation Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and deli Terminated |
LKK | None listed |
| Dec 13, 2012 | Medtronic Neuromodulation SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a Synch Terminated |
LKK | None listed |
| Mar 30, 2012 | Medtronic Neuromodulation Medtronic, Model 8870, Application Software Card is part of the SynchroMed II Drug Infusion System. The System includes the SynchroMed II implantable drug infusion pump 8637-20, 8637-40, N'Vision cli Terminated |
LKK | None listed |
| Aug 29, 2011 | Medtronic, Inc. - Neuromodulation Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and d Terminated |
LKK | None listed |
| Feb 10, 2011 | Medtronic, Inc. - Neuromodulation Medtronic SynchroMed EL (Model No: 8626 and 8627) implantable drug pump
The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. Terminated |
LKK | None listed |
| Feb 10, 2011 | Medtronic, Inc. - Neuromodulation Medtronic SynchroMed implantable drug pump
Refill Kits (Model No: 8551, 8555, 8561, 8562, 8564, 8565, 8566
The Model 8551, 8555, 8561, 8562, 8564, 8565, and 8566 Refill Kits are intended for use i Terminated |
LKK | None listed |
| Feb 10, 2011 | Medtronic, Inc. - Neuromodulation Medtronic SynchroMed II (Model No: 8637) implantable drug pump
The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Terminated |
LKK | None listed |
| Nov 9, 2010 | Medtronic, Inc. - Neuromodulation Medtronic Intrathecal Catheter Spinal Segment Revision Kit, 8598A. Method of Sterilization: Ethylene Oxide. Manufacturer Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. Th Terminated |
LKK | None listed |
| Nov 9, 2010 | Medtronic, Inc. - Neuromodulation Medtronic Intrathecal Catheter, 8731SC with sutureless connector. Method of Sterilization: Ethylene Oxide. Manufacturer Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 The impl Terminated |
LKK | None listed |
| Mar 29, 2010 | Medtronic Neuromodulation Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA. Terminated |
LKK | None listed |
| Sep 29, 2009 | Medtronic Neuromodulation Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Minneapolis, MN 55432-5604. (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir Terminated |
LKK | None listed |
| Sep 10, 2009 | Medtronic Neuromodulation Medtronic Sutureless Pump Connector Revision Kit, model 8578, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The 8578 revision kit catheter connects to Terminated |
LKK | None listed |
| Sep 10, 2009 | Medtronic Neuromodulation Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. Contents: 66-cm-pump segment w Terminated |
LKK | None listed |
| Sep 10, 2009 | Medtronic Neuromodulation Medtronic Intrathecal Catheter, model 8731SC, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The 8731SC catheter is a two-piece catheter with a thin-wa Terminated |
LKK | None listed |
| Sep 10, 2009 | Medtronic Neuromodulation Medtronic Indura 1P Intrathecal Catheter, model 8709SC, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The implanted infusion system components consist o Terminated |
LKK | None listed |
| Jan 26, 2009 | Medtronic Neuromodulation Medtronic SynchroMed II Programmable Pump, Model 8637-40. 40 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroM Terminated |
LKK | None listed |
| Jan 26, 2009 | Medtronic Neuromodulation Medtronic SynchroMed II Programmable Pump, Model 8637-20. 20 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroM Terminated |
LKK | None listed |
| Jan 26, 2009 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8627L-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic Synchro Terminated |
LKK | None listed |
| Jan 26, 2009 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8627-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroM Terminated |
LKK | None listed |
| Jan 26, 2009 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8627L-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic Synchro Terminated |
LKK | None listed |
| Jan 26, 2009 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8627-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroM Terminated |
LKK | None listed |
| Jan 26, 2009 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic Synchro Terminated |
LKK | None listed |
| Jan 26, 2009 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8626-18. 18 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroM Terminated |
LKK | None listed |
| Jan 26, 2009 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8626L-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic Synchro Terminated |
LKK | None listed |
| Jan 26, 2009 | Medtronic Neuromodulation Medtronic SynchroMed EL Programmable Pump, Model 8626-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroM Terminated |
LKK | None listed |
| Sep 25, 2008 | Medtronic Neuromodulation Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 66-cm pump segment with attached sutureless pump connector, spinal segment strain-relief sleeves (2), Pump segment s Terminated |
LKK | None listed |
| Sep 25, 2008 | Medtronic Neuromodulation Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: Catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve, Strain-relief S Terminated |
LKK | None listed |
| Sep 25, 2008 | Medtronic Neuromodulation Medtronic Intrathecal Catheter, model 8731SC. 38.1 cm spinal segment with length markers and guide wire, 66 cm pump segment, separate connector pin, 15T gauge introducer needles (2) (11.4 cm and 9.3 Terminated |
LKK | None listed |
| Sep 25, 2008 | Medtronic Neuromodulation Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. 81.4 cm catheter with length markers and guide wire, 15 T-guage introducer needle, Sutureless pump connector with attached 7.6 cm catheter and Terminated |
LKK | None listed |
| Sep 17, 2008 | Medtronic Neuromodulation IsoMed Refill Kit, Model 8553, Lot Number 60538731, is intended for use in refilling Medtronic IsoMed pumps. Contents: Two 22-gauge needles, extension tubing set with y-connector and clamp, Filter, 10 Terminated |
LKK | None listed |
| Sep 3, 2008 | Medtronic Neuromodulation Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604
40 ml Pumps Model 8637-40
The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed Terminated |
LKK | None listed |
| Sep 3, 2008 | Medtronic Neuromodulation Medtronic Synchromed II Programmable Pump , Medtronic Inc., Minneapolis, MN 55432-5604
20 ml Pumps Model 8637-20
The implantable Medtronic SynchroMed II Programmable Pump is part of the SynchroMed II Terminated |
LKK | None listed |
| Aug 27, 2008 | Medtronic Neuromodulation Model 8731SC Intrathecal Catheter
Medtronic Inc., Minneapolis, MN 55432
A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therap Terminated |
LKK | None listed |
| Aug 27, 2008 | Medtronic Neuromodulation Model 8709SC Indura 1P
One-Piece Intrathecal Catheter
Medtronic Inc., Minneapolis, MN 55432
A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administ Terminated |
LKK | None listed |
| Aug 27, 2008 | Medtronic Neuromodulation Model 8596SC Intrathecal Catheter Pump Segment Revision Kit
Medtronic Inc., Minneapolis, MN 55432
A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal adm Terminated |
LKK | None listed |
| Aug 27, 2008 | Medtronic Neuromodulation Medtronic 8578 Sutureless Pump Connector Revision Kit
Medtronic Inc., Minneapolis, MN 55432
A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administr Terminated |
LKK | None listed |
| Jul 22, 2008 | Medtronic Neuromodulation Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number: 8596SC; Packaged with catheter model number 8731 or 8731SC. Terminated |
LKK | None listed |
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-60. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 60 mL. Medtronic, Inc., 710 Terminated |
LKK | None listed |
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-35. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 35 mL. Medtronic, Inc., 710 Terminated |
LKK | None listed |
| Mar 22, 2008 | Medtronic Neuromodulation Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-20. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 20 mL. Medtronic, Inc., 710 Terminated |
LKK | None listed |
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