• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device endovascular suturing system
Regulation Description Endovascular Suturing System.
Definition Provides fixation and sealing between and endovascular graft and the native artery.
Product CodeOTD
Regulation Number 870.3460
Device Class 2


Premarket Reviews
ManufacturerDecision
APTUS ENDOSYSTEMS, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Leak 61
No Known Device Problem 28
Break 13
Dislodged or dislocated 11
Device Difficult to Setup or Prepare 6
Device operates differently than expected 2
Packaging issue 2
Positioning Issue 2
Material deformation 2
Foreign material present in device 1
Air leak 1
Device or device component damaged by another device 1
Inability to irrigate 1
Difficult to insert 1
Device expiration issue 1
Deployment issue 1
Delivered as unsterile product 1
Total Device Problems 135

-
-