Duns Number:482661753
Device Description: ENVOY DA Guiding Catheter STR 105cm 6F (2.0mm) 0.071 Inches (1.8mm)
Catalog Number
67126005D
Brand Name
ENVOY
Version/Model Number
671-260-05D
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
K140080
Product Code
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
721cd43e-42ee-4050-8a74-f67e338eae3a
Public Version Date
December 22, 2021
Public Version Number
7
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 |