510(k) K061727
- Device
- GORE PRECLUDE VESSEL GUARD
- Applicant
- W.L. GORE & ASSOCIATES,INC
- 510(k) number
- K061727
- Product code
- MFX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-08-07
- Date received
- 2006-06-19
- Regulation
- 870.3470
- Classification name
- Vessel Guard Or Cover, To Facilitate Revision Surgeries
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Ivey
- Address
- 1505 N. Fourth St. Flagstaff AZ US 86003 86003
FDA Registration Numbers#
- 1220948
Source Documents#
Other 510(k) Records For Product Code MFX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K960532 | PRECLUDE IMA SLEEVE | W. L. Gore & Associates, Inc. | 1996-05-23 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases