Atlas FDA

GORE-TEX PERITONEAL CATHETERR

FDA 510(k) clearance K820909 · decided 1982-05-21

Clearance details

K-number
K820909
Device name
GORE-TEX PERITONEAL CATHETERR
Applicant
W. L. Gore & Associates, Inc.
Decision
Substantially Equivalent
Date received
1982-04-01
Decision date
1982-05-21
Days to decision
50 days
Clearance type
Traditional
Product code
FJS
Device class
2
Regulation number
876.5630
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560 (K071167)Medigroup, Inc.2007-08-31
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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