510(k) K082348 ยท NTE Temporary Carotid Catheter For Embolic Capture
FIBERNET EMBOLIC PROTECTION SYSTEM
| Applicant | Lumen Biomedical, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Nov 18, 2008 |
| Received | Aug 15, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082348
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2014 | Medtronic Vascular, Inc. FIBERNET Embolic Protection System:
Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm)
Rx only, Sterile;
Manufactured in:
Invatec S.P.A., Italy;
Manufacturer:
Me Terminated |
NTE | None listed |
| Mar 27, 2014 | Medtronic Vascular, Inc. FIBERNET Embolic Protection System:
Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter:
0.014 in (0.36mm)
Rx only, Sterile;
Manufactured in:
Invatec S.P.A., Italy;
Manufacturer:
Medtr Terminated |
NTE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.