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Found 3 results
510(k) Data Aggregation
K Number
K162453Device Name
13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
Manufacturer
Pan Medical Ltd.
Date Cleared
2016-11-01
(61 days)
Product Code
NDN, HRX
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
Pan Medical Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
8G InterV Kyphoplasty Catheter, 11G InterV Kyphoplasty Catheter (Mini), 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Flex) are intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).
Device Description
Both the predicate and the subject InterV Kyphoplasty Catheters are designed for use in balloon kyphoplasty; they come as a single-use double lumen catheter with a low profile balloon mounted on the distal tip. The balloon is designed to compress cancellous bone and/or move cortical bone as it inflates. The key components are the balloon, shaft, Y-connector and two radiopaque marker bands positioned on the inner tubing/lumen at the proximal and distal ends of the inflatable component.
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K Number
K150322Device Name
InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)
Manufacturer
PAN MEDICAL LTD
Date Cleared
2015-03-06
(25 days)
Product Code
NDN, HRX
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
PAN MEDICAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterV Kyphoplasty Catheter is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).
Device Description
Both the unmodified predicate and the subject modified InterV Kyphoplasty Catheter are designed for use in balloon kyphoplasty; they come as a single-use double lumen catheter with a low profile balloon mounted on the distal tip. The balloon is designed to compress cancellous bone and/or move cortical bone as it inflates. The key components are the balloon, shaft, Y-connector and two radiopaque marker bands positioned on the inner tubing/lumen at the proximal and distal ends of the inflatable component.
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K Number
K132620Device Name
INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
Manufacturer
PAN MEDICAL LTD
Date Cleared
2014-04-16
(238 days)
Product Code
NDN, HRX
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
PAN MEDICAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
InterV Kyphoplasty Catheter is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).
Device Description
InterV Kyphoplasty Catheter is designed for use in balloon kyphoplasty; it comes as a single-use double lumen catheter with a low profile balloon mounted on the distal tip. The balloon is designed to compress cancellous bone and/or move cortical bone as it inflates. The balloon is designed to withstand bone resistance leading to an a internal pressure of up to 400 psi (27 ATM). The key components are the balloon, shaft, Y-connector and two radiopaque marker bands positioned on the inner tubing/lumen at the proximal and distal ends of the inflatable component
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