Duns Number:008999906
Device Description: The EXPRO Elite Snares are intended for use in the cardiovascular system and hollow viscus The EXPRO Elite Snares are intended for use in the cardiovascular system and hollow viscus to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.
Catalog Number
-
Brand Name
Expro Elite™ snare
Version/Model Number
8401
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
MMX
Product Code Name
Device, Percutaneous Retrieval
Public Device Record Key
c69d76a0-9e30-4ab7-8b29-f3a9fd75f1bf
Public Version Date
July 08, 2021
Public Version Number
5
DI Record Publish Date
September 05, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |