DEVICE: ELM PTA Balloon Dilatation Catheter (05391525781181)
Device Identifier (DI) Information
ELM PTA Balloon Dilatation Catheter
ELMEX1440L
In Commercial Distribution
CREAGH MEDICAL LIMITED
ELMEX1440L
In Commercial Distribution
CREAGH MEDICAL LIMITED
ELM Extension HP PTA 14mm x 40mm x 75cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
17184 | Peripheral angioplasty balloon catheter, basic |
A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LIT | Catheter, Angioplasty, Peripheral, Transluminal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K143561 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 40 Millimeter |
Outer Diameter: 14.0 Millimeter |
Device Record Status
a9897473-76f5-42a3-adb2-951f0948b370
August 09, 2019
4
September 22, 2016
August 09, 2019
4
September 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined