Duns Number:690535406
Device Description: R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Cath R2P CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. R2P CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
Catalog Number
BD-Q25020ER
Brand Name
R2P CROSSTELLA RX
Version/Model Number
BD-Q25020ER
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
K152873
Product Code
LIT
Product Code Name
Catheter, Angioplasty, Peripheral, Transluminal
Public Device Record Key
ea8c70fa-2916-4ed1-b3a4-22e5f3c47e5e
Public Version Date
August 09, 2019
Public Version Number
2
DI Record Publish Date
June 01, 2019
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 |