Atlas FDA

GORE Tri-Lumen Catheter

FDA 510(k) clearance K180919 · decided 2018-10-05

Clearance details

K-number
K180919
Device name
GORE Tri-Lumen Catheter
Applicant
W. L. Gore and Associates, Inc.
Decision
Substantially Equivalent
Date received
2018-04-09
Decision date
2018-10-05
Days to decision
179 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® EXCLUDER® Conformable AAA Endoprosthesis (P200030/S023)W. L. Gore and Associates, Inc.2025-12-05
GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) 00733132650927; 00733132650934; 00733132650941; 00733132650958; 00 (P200030/S022)W. L. Gore and Associates, Inc.2025-08-29
GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) (P200030/S021)W. L. Gore and Associates, Inc.2025-06-05
GORE EXCLUDER Conformable AAA Endoprosthesis (P200030/S020)W. L. Gore and Associates, Inc.2025-06-05
GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S019)W. L. Gore and Associates, Inc.2025-03-11
GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (P200030/S016)W. L. Gore and Associates, Inc.2024-12-04
GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S018)W. L. Gore and Associates, Inc.2024-09-06
Gore Excluder Conformable AAA Endoprosthesis (CEXC) (P200030/S017)W. L. Gore and Associates, Inc.2024-06-21