FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEP-RINGED GORE-TEX@ VASCULAR GRAFT
K Number: K821826
·
Decision Dec 29, 1982
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
20
Applicant Total
163
Review Days
190
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Basic Information
- Device Name
- FEP-RINGED GORE-TEX@ VASCULAR GRAFT
- K Number
- K821826
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- W. L. Gore & Associates, Inc.
- Date Received
- June 22, 1982
- Decision Date
- December 29, 1982
- Product Code
- DYF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYF), ordered by most recent decision date.
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ADVANTA GRAFT
FDA 510(k)
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PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by W. L. Gore & Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250410 | GORE® Tri-Lobe Balloon Catheter | Jun 2, 2025 | Substantially Equivalent |
| K240083 | GORE® PROPATEN® Vascular Graft | Mar 1, 2024 | Substantially Equivalent |
| K232312 | GORE® PROPATEN® Vascular Graft | Jan 9, 2024 | Substantially Equivalent |
| K233551 | GORE® ACUSEAL Vascular Graft | Dec 19, 2023 | Substantially Equivalent |
| K231505 | GORE® ACUSEAL Vascular Graft | Jun 23, 2023 | Substantially Equivalent |
| K191773 | GORE BIO-A Tissue Reinforcement | Jul 31, 2019 | Substantially Equivalent |
| K181940 | GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement | Aug 17, 2018 | Substantially Equivalent |
| K173333 | GORE ENFORM Biomaterial | Apr 5, 2018 | Substantially Equivalent |
| K163576 | GORE SYNECOR Preperitoneal Biomaterial | May 11, 2017 | Substantially Equivalent |
| K170740 | GORE VIABIL Short Wire Biliary Endoprosthesis | May 8, 2017 | Unknown |