DEVICE: METACROSS RX (04540778153134)
Device Identifier (DI) Information
METACROSS RX
BD-L30020ER
In Commercial Distribution
BD-L30020ER
KANEKA CORPORATION
BD-L30020ER
In Commercial Distribution
BD-L30020ER
KANEKA CORPORATION
METACROSS RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. METACROSS RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.035 inches (0.89 mm).
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQY | Catheter, Percutaneous |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150865 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Maximum Guidewire Diameter; 0.035 inch |
Device Size Text, specify: Compatible Sheath Diameter; 6 Fr |
Device Size Text, specify: Rated Burst Pressure; 20 atm |
Device Size Text, specify: Nominal Pressure; 10 atm |
Device Size Text, specify: Proximal Shaft Diameter; 3.9 Fr |
Device Size Text, specify: Distal Shaft Diameter; 5.7 Fr |
Device Size Text, specify: Catheter Working Length; 2000 mm |
Device Size Text, specify: Balloon Length; 20 mm |
Device Size Text, specify: Balloon Diameter; 3.0 mm |
Device Record Status
d66f2256-0f0b-4ba3-897b-f7f5e2f41155
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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