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

Establishment Registration & Device Listing
  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Proprietary Name: Ampere Generator; Ampere™ Footswitch; Ampere™ Generator Accessories; Ampere™ Generator Fiber Cord Assembly Remote; Ampere™ Generator Kit; Ampere™ Remote Control; FlexAbility Ablation Catheter; FlexAbility Ablation Catheter, Sensor Enabled; IBI 1500T9-CP V1.6 Cardiac Ablation Generator; Safire BLU Duo Ablation Catheter; Sensor Enabled™ Ablation Connection Cable; Therapy Cool Flex Ablation Catheter; Therapy Cool Path Duo Ablation Catheter
Classification Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
Product Code: OAD
Device Class: 3
Registered Establishment Name: IRVINE BIOMEDICAL. INC.
Registered Establishment Number: 2030404
Premarket Submission Number: P110016
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Manufacturer
-
-