Duns Number:015510540
Device Description: 5.0Fr x 10cm Tearaway Sheath Dilator Introducer Set
Catalog Number
5053-003
Brand Name
V-Cath
Version/Model Number
5053-003
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
K951384,K951384
Product Code
KZH
Product Code Name
Introducer, Syringe Needle
Public Device Record Key
4b3a9833-81ac-49e9-b497-98b467add9f3
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
B33950530035
Quantity per Package
10
Contains DI Package
B33950530030
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |