Duns Number:482661753
Device Description: ASCENT balloon catheter Occlusion Balloon Catheter 4mm x 15mm 150 cm 3 mm 2.9 F (0.98 mm) ASCENT balloon catheter Occlusion Balloon Catheter 4mm x 15mm 150 cm 3 mm 2.9 F (0.98 mm) 0.0170 Inch (0.43 mm) Contents: 1 ASCENT Occlusion Balloon Catheter
Catalog Number
BRC00041500
Brand Name
ASCENT
Version/Model Number
BRC000415-00
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
K103780
Product Code
MJN
Product Code Name
Catheter, intravascular occluding, temporary
Public Device Record Key
249aa8bf-76f8-414e-8522-4d8e86fd36ef
Public Version Date
March 21, 2019
Public Version Number
4
DI Record Publish Date
June 30, 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 | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |