Duns Number:413008652
Device Description: The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passag The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices. No(0) side holes in the tip section.
Catalog Number
H74939264080
Brand Name
Convey
Version/Model Number
6FConvey FL4.5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K120585
Product Code
DQY
Product Code Name
Catheter, Percutaneous
Public Device Record Key
6dd9af1b-c3e3-4b30-bb32-a073c5691503
Public Version Date
December 22, 2021
Public Version Number
7
DI Record Publish Date
May 01, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 533 |