ClearanceBrief
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)
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Top companies in LKK

DateFirm and productCodeLinked 510(k)
Jul 16, 2013Codman & 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
LKKNone listed
Jul 16, 2013Codman & 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
LKKNone listed
Jun 25, 2013Medtronic 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
LKKNone listed
Jun 25, 2013Medtronic 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
LKKNone listed
Jun 25, 2013Medtronic 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
LKKNone listed
Jun 25, 2013Medtronic 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
LKKNone listed
Jun 24, 2013Medtronic 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
LKKNone listed
Jun 24, 2013Medtronic 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
LKKNone listed
Jun 24, 2013Medtronic 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
LKKNone listed
Jun 24, 2013Medtronic 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
LKKNone listed
Dec 13, 2012Medtronic 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
LKKNone listed
Dec 13, 2012Medtronic 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
LKKNone listed
Mar 30, 2012Medtronic 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
LKKNone listed
Aug 29, 2011Medtronic, 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
LKKNone listed
Feb 10, 2011Medtronic, 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
LKKNone listed
Feb 10, 2011Medtronic, 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
LKKNone listed
Feb 10, 2011Medtronic, 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
LKKNone listed
Nov 9, 2010Medtronic, 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
LKKNone listed
Nov 9, 2010Medtronic, 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
LKKNone listed
Mar 29, 2010Medtronic 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
LKKNone listed
Sep 29, 2009Medtronic 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
LKKNone listed
Sep 10, 2009Medtronic 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
LKKNone listed
Sep 10, 2009Medtronic 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
LKKNone listed
Sep 10, 2009Medtronic 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
LKKNone listed
Sep 10, 2009Medtronic 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
LKKNone listed
Jan 26, 2009Medtronic 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
LKKNone listed
Jan 26, 2009Medtronic 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
LKKNone listed
Jan 26, 2009Medtronic 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
LKKNone listed
Jan 26, 2009Medtronic 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
LKKNone listed
Jan 26, 2009Medtronic 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
LKKNone listed
Jan 26, 2009Medtronic 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
LKKNone listed
Jan 26, 2009Medtronic 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
LKKNone listed
Jan 26, 2009Medtronic 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
LKKNone listed
Jan 26, 2009Medtronic 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
LKKNone listed
Jan 26, 2009Medtronic 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
LKKNone listed
Sep 25, 2008Medtronic 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
LKKNone listed
Sep 25, 2008Medtronic 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
LKKNone listed
Sep 25, 2008Medtronic 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
LKKNone listed
Sep 25, 2008Medtronic 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
LKKNone listed
Sep 17, 2008Medtronic 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
LKKNone listed
Sep 3, 2008Medtronic 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
LKKNone listed
Sep 3, 2008Medtronic 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
LKKNone listed
Aug 27, 2008Medtronic 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
LKKNone listed
Aug 27, 2008Medtronic 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
LKKNone listed
Aug 27, 2008Medtronic 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
LKKNone listed
Aug 27, 2008Medtronic 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
LKKNone listed
Jul 22, 2008Medtronic Neuromodulation
Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number: 8596SC; Packaged with catheter model number 8731 or 8731SC.
Terminated
LKKNone listed
Mar 22, 2008Medtronic 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
LKKNone listed
Mar 22, 2008Medtronic 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
LKKNone listed
Mar 22, 2008Medtronic 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
LKKNone listed

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