Duns Number:008999906
Device Description: The Amplatz SST Steerable Guidewire facilitates placement of a catheter during diagnostic The Amplatz SST Steerable Guidewire facilitates placement of a catheter during diagnostic angiography and interventional procedures. The Amplatz SST can be accurately controlled ot facilitate navigation through tortuous vessels and/or adjoining side branches.
Catalog Number
-
Brand Name
Amplatz SST™ guidewire
Version/Model Number
7489
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
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
38cc2466-f651-4c4a-b1f5-4e25616e8a3a
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
September 05, 2016
Package DI Number
M20674891
Quantity per Package
5
Contains DI Package
M20674890
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| 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 |