Duns Number:482661753
Device Description: PROWLER 14 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.9F (0.65 mm PROWLER 14 Infusion Catheter with 2 Markers Infusion Catheter 2.3F (0.75 mm) 1.9F (0.65 mm) .0165 Inch (0.4 mm) 3cm 50 cm 150 cm MAX Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .035 Inch (0.9 mm)
Catalog Number
606151MX
Brand Name
PROWLER
Version/Model Number
606-151MX
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
K003925,K993266
Product Code
KRA
Product Code Name
Catheter, continuous flush
Public Device Record Key
9eed0636-b900-4a59-b934-5d0268441791
Public Version Date
March 04, 2020
Public Version Number
6
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 |