DEVICE: Apollo Balloon Dilatation Catheter (06958481413182)

Device Identifier (DI) Information

Apollo Balloon Dilatation Catheter
rev 01
In Commercial Distribution
802-2712U
BrosMed Medical Co.,Ltd.
06958481413182
GS1

1
421318800 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Coronary angioplasty balloon catheter, basic A sterile, flexible tube designed to be used in percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent in the coronary arteries. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K133852 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

31d4a446-af09-4b3f-b8b5-2f8df01a6fd6
July 06, 2018
3
September 10, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
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Yes
No
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Customer Contact

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No Customer Contact currently defined
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