Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 show TPLC since Back to Search Results
Device clip, aneurysm
Regulation Description Aneurysm clip.
Product CodeHCH
Regulation Number 882.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
MIZUHO AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 13 13
2022 1 1
2023 10 10
2024 9 9
2025 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Seal 15 15
Mechanical Problem 4 4
Material Integrity Problem 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Break 2 2
Migration or Expulsion of Device 2 2
Difficult to Open or Close 2 2
Mechanical Jam 2 2
Activation Problem 1 1
Difficult to Fold, Unfold or Collapse 1 1
Insufficient Information 1 1
Wrong Label 1 1
Material Twisted/Bent 1 1
Product Quality Problem 1 1
Device Dislodged or Dislocated 1 1
Failure to Form Staple 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
Insufficient Information 6 6
Aneurysm 4 4
Failure of Implant 2 2
Hemorrhage/Bleeding 2 2
Ruptured Aneurysm 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Peter Lazic Gmbh II Mar-12-2024
-
-