FDA 510(k) K240083, GORE® PROPATEN® Vascular Graft, by W. L. Gore & Associates, Inc.
FDA 510(k) K240083, GORE® PROPATEN® Vascular Graft, by W. L. Gore & Associates, Inc.
FDA 510(k) records for GORE® PROPATEN® Vascular Graft (K240083), submitted by W. L. Gore & Associates, Inc..
- 510(k) Number: K240083
- Device Classification: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Applicant: W. L. Gore & Associates, Inc.
- Date Received: 01/11/2024
- Decision Date: 03/01/2024
- Decision: Substantially Equivalent (SESE)
- Regulation Number: 870.345
- Product Code: DSY
- Regulation Medical Specialty: Cardiovascular
- Review Panel: Cardiovascular
- Total Pages: 801 (452 unredacted, 43% redacted overall)
What's in this document (sections may appear in any order):
- — 510(k) Summary / Statement: no distinct section found
- — Indications for Use: no distinct section found
- — Device Description: no distinct section found
- — Substantial Equivalence / Predicate: no distinct section found
- — Performance / Bench Testing: no distinct section found
- — Biocompatibility: no distinct section found
- — Software / Cybersecurity: no distinct section found
- — Sterilization / Shelf Life: no distinct section found
- — Labeling / IFU: no distinct section found
- — Clinical Data: no distinct section found
- — FDA Correspondence: no distinct section found
- — Risk Analysis / FMEA: no distinct section found
- — Electromagnetic Compatibility (EMC): no distinct section found
Section contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.
Couldn't load pickup availability
PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.
View full details