DEVICE: Minerva PTA Balloon Dilatation Catheter (06958481414387)
Device Identifier (DI) Information
Minerva PTA Balloon Dilatation Catheter
rev 01
In Commercial Distribution
803-030010-070U
BrosMed Medical Co.,Ltd.
rev 01
In Commercial Distribution
803-030010-070U
BrosMed Medical Co.,Ltd.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
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 microsurgical blades (atherotomes) to score the plaque. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
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LIT | Catheter, Angioplasty, Peripheral, Transluminal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K160256 | 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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No Device Sizes |
Device Record Status
ec9fabab-baaa-4580-b20b-591cc0fb08cb
July 06, 2018
3
October 31, 2016
July 06, 2018
3
October 31, 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