DEVICE: Chocolate® PTA Balloon Catheter (00763000115166)

Device Identifier (DI) Information

Chocolate® PTA Balloon Catheter
CB1415025040OTW
In Commercial Distribution

MEDTRONIC, INC.
00763000115166
GS1

1
006261481 *Terms of Use
PTA CB1415025040 CHOCOLATE 014
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LIT Catheter, angioplasty, peripheral, transluminal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K130414 000
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a dry, cool place.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

5a8e4517-d434-4d60-a8a6-faab562133b1
August 09, 2019
3
May 27, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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