Duns Number:482661753
Device Description: YOGA 28XB Microcatheter 0.028 Inch I.D. - 150cm - Straight 3.0F (1.02mm) 2.7F (0.92mm) 0.0 YOGA 28XB Microcatheter 0.028 Inch I.D. - 150cm - Straight 3.0F (1.02mm) 2.7F (0.92mm) 0.028 Inch (0.71mm) Contents: 1 Microcatheter and 1 Shaping Mandrel
Catalog Number
MC28150ZB
Brand Name
YOGA
Version/Model Number
MC28150ZB
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
K171653
Product Code
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
f51f3d3c-ce4a-44cc-ba52-54b63ae5a529
Public Version Date
December 22, 2021
Public Version Number
7
DI Record Publish Date
October 31, 2017
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 |