Duns Number:989214291
Device Description: Caterpillar Arterial Embolization Device, 0.038 Inch ID Catheter Compatibility
Catalog Number
CTP038020U
Brand Name
Caterpillar
Version/Model Number
CTP038020U
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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"
Yes
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
K191532
Product Code
KRD
Product Code Name
Device, Vascular, for Promoting Embolization
Public Device Record Key
16dc2940-3dc2-42c0-b309-f4ddd1b79a03
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
February 13, 2020
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. | 228 |
| 3 | A medical device with high risk that requires premarket approval | 42 |