DEVICE: CROSPERIO OTW (04540778164659)
Device Identifier (DI) Information
CROSPERIO OTW
BD-B35200MW
In Commercial Distribution
BD-B35200MW
KANEKA CORPORATION
BD-B35200MW
In Commercial Distribution
BD-B35200MW
KANEKA CORPORATION
CROSPERIO OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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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 |
---|---|
LIT | Catheter, Angioplasty, Peripheral, Transluminal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K160013 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight. |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Maximum Guidewire Diameter; 0.014 inch |
Device Size Text, specify: Compatible Sheath Diameter; 4 Fr |
Device Size Text, specify: Rated Burst Pressure; 14 atm |
Device Size Text, specify: Nominal Pressure; 8 atm |
Device Size Text, specify: Shaft Diameter; 3.8 Fr |
Device Size Text, specify: Catheter Working Length; 900 mm |
Device Size Text, specify: Balloon Length; 200 mm |
Device Size Text, specify: Balloon Diameter; 3.5 mm |
Device Record Status
eb849abc-8740-4cc2-b3c0-ab692d62899a
July 06, 2018
3
August 26, 2016
July 06, 2018
3
August 26, 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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-888-3786
tmccustomer.admin@terumomedical.com
tmccustomer.admin@terumomedical.com