Duns Number:532245789
Device Description: The TSP Crosser System is intended to be used both to puncture the interatrial septum duri The TSP Crosser System is intended to be used both to puncture the interatrial septum during a transseptal catheterization procedure and to introduce various cardiovascular catheters into the left heart chambers.
Catalog Number
-
Brand Name
TSP Crosser Transseptal Access System
Version/Model Number
TSUS001
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
-
Product Code
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
03fdc336-461d-432c-b1b2-b6e6edd6471c
Public Version Date
May 09, 2019
Public Version Number
4
DI Record Publish Date
April 19, 2019
Package DI Number
57290017811012
Quantity per Package
5
Contains DI Package
07290017811017
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipment box 5 pack