Atlas FDA

GORE TRI-LOBE BALLOON CATHETER

FDA 510(k) clearance K081799 · decided 2008-10-03

Clearance details

K-number
K081799
Device name
GORE TRI-LOBE BALLOON CATHETER
Applicant
W. L. Gore & Associates, Inc.
Decision
Substantially Equivalent
Date received
2008-06-25
Decision date
2008-10-03
Days to decision
100 days
Clearance type
Traditional
Product code
DQY
Device class
2
Regulation number
870.1250
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Flagstaff, AZ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
GORE® VIABAHN® FORTEGRA Venous Stent (P250017)W. L. Gore & Associates, Inc.2025-12-19
GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder (P050006/S116)W. L. Gore & Associates, Inc.2025-12-19
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S048)W. L. Gore & Associates, Inc.2025-11-24
GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S099)W. L. Gore & Associates, Inc.2025-10-27
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S110)W. L. Gore & Associates, Inc.2025-10-17
GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S171)W. L. Gore & Associates, Inc.2025-10-17
GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S024)W. L. Gore & Associates, Inc.2025-10-17
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S049)W. L. Gore & Associates, Inc.2025-10-17