Duns Number:968903703
Device Description: PTA A14BX040040170 RAPIDCROSS V03
Catalog Number
-
Brand Name
RapidCross™
Version/Model Number
A14BX040040170
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
K130911
Product Code
LIT
Product Code Name
Catheter, angioplasty, peripheral, transluminal
Public Device Record Key
021ddca8-41fa-4b1a-83c6-212a9a94cdbe
Public Version Date
August 09, 2019
Public Version Number
4
DI Record Publish Date
April 16, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |