Duns Number:482661753
Device Description: Large Bore Catheter 0.085 in (2.16 mm) Minimum Guide Diameter Proximal OD: 0.0825 in / 2.1 Large Bore Catheter 0.085 in (2.16 mm) Minimum Guide Diameter Proximal OD: 0.0825 in / 2.10 mm Distal OD: 0.0810 in / 2.06 mm ID: 0.071 in / 1.80 mm Working length: 132 cm
Catalog Number
IC71132UG
Brand Name
N/A
Version/Model Number
IC71132UG
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
K191237
Product Code
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
6b248fee-e501-4ae9-94e3-763296192e44
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
December 02, 2019
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 |