DEVICE: Cronus™ HP - OTW PTA BALLOON CATHETER (00383790004244)
Device Identifier (DI) Information
Cronus™ HP - OTW PTA BALLOON CATHETER
NCH+84045
In Commercial Distribution
NIPRO MEDICAL CORPORATION
NCH+84045
In Commercial Distribution
NIPRO MEDICAL CORPORATION
OTW High Pressure Peripheral Balloon Catheter
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
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 [?] |
---|---|
K151141 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: balloon diameter: 8mm |
Device Size Text, specify: balloon length: 40mm |
Device Size Text, specify: catheter length: 45cm |
Device Record Status
d7eb3a6a-3e0c-40c1-b03c-701fd07a5145
July 06, 2018
3
September 16, 2016
July 06, 2018
3
September 16, 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
[?]
+1 (908) 393-7030
info@nipromed.com
info@nipromed.com