DEVICE: CROSSTELLA OTW (04540778160972)
Device Identifier (DI) Information
CROSSTELLA OTW
BD-F30100MW
In Commercial Distribution
BD-F30100MW
KANEKA CORPORATION
BD-F30100MW
In Commercial Distribution
BD-F30100MW
KANEKA CORPORATION
CROSSTELLA OTW is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA OTW is an over the wire (OTW) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46 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 [?] |
---|---|
K160004 | 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; 0.018 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; 3.9 Fr |
Device Size Text, specify: Catheter Working Length; 900 mm |
Device Size Text, specify: Balloon Length; 100 mm |
Device Size Text, specify: Balloon Diameter; 3.0 mm |
Device Record Status
6cda7982-44e2-4152-9198-b72e23b85844
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