Duns Number:690535406
Device Description: RX TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Ca RX TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. RX TAKERU is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
Catalog Number
DC-RY3520UA2
Brand Name
RX TAKERU
Version/Model Number
DC-RY3520UA2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K163372
Product Code
LOX
Product Code Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Public Device Record Key
2e581ba3-417d-4ec8-a9a7-339052230b78
Public Version Date
October 07, 2019
Public Version Number
4
DI Record Publish Date
June 01, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1041 |
| U | Unclassified | 1 |