Duns Number:002348191
Device Description: ARROW(R) GlideThru(TM) Peel-Away Sheath over DilatorDilator accepts .018" dia. or smaller ARROW(R) GlideThru(TM) Peel-Away Sheath over DilatorDilator accepts .018" dia. or smaller Spring-Wire Guide.Sheath accepts 5.5 Fr. or smaller catheter.
Catalog Number
PL-01055
Brand Name
ARROW
Version/Model Number
IPN035882
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"
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
K122854,K122854
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
bfe52665-a2b1-4f94-bcff-5f178ab3bd90
Public Version Date
April 27, 2020
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
30801902080326
Quantity per Package
10
Contains DI Package
00801902080325
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |