Duns Number:482661753
Device Description: ENVOY XB Guiding Catheter CBL MOD (BURKE) 100 cm 7F (2.3 mm) .078 Inch (2.0 mm)
Catalog Number
77824800B
Brand Name
ENVOY
Version/Model Number
778-248-00B
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
K140307
Product Code
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
6bdd36d0-7d8b-4e9a-a8ee-794919dea677
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
January 29, 2020
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 |