DEVICE: CROSPERIO RX (04540778162778)
Device Identifier (DI) Information
CROSPERIO RX
BD-B25150MR
In Commercial Distribution
BD-B25150MR
KANEKA CORPORATION
BD-B25150MR
In Commercial Distribution
BD-B25150MR
KANEKA CORPORATION
CROSPERIO RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSPERIO RX is a rapid exchange (RX) 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 | |
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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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K152887 | 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: Proximal Shaft Diameter; 3.5 Fr |
Device Size Text, specify: Distal Shaft Diameter; 3.5 Fr |
Device Size Text, specify: Catheter Working Length; 900 mm |
Device Size Text, specify: Balloon Length; 150 mm |
Device Size Text, specify: Balloon Diameter; 2.5 mm |
Device Record Status
238fc948-d31e-463a-9402-e57ec3862306
August 09, 2019
4
August 26, 2016
August 09, 2019
4
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