510(k) K091987 ยท FZP Clip, Implantable
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
| Applicant | LeMaitre Vascular, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Apr 23, 2010 |
| Received | Jul 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091987
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2010 | Lemaitre Vascular, Inc. LeMaitre Vascular AnastoClip GC Vessel Closure System-Medium Size
Models:
4007-02 Medium size 3 Pack
4008-02 Medium size 10 Pack
4007-06 Medium size 1 Pack
Manufactured by LeMatire Vascular Inc, Burli Terminated |
HBT | None listed |
| Oct 28, 2010 | Lemaitre Vascular, Inc. LeMaitre Vascular AnastoClip GC Vessel Closure System-Large Size
Models:
4007-03 Large size 3 Pack
4008-03 Large size 10 Pack
4007-07 Large size 1 Pack
Manufactured by LeMatire Vascular Inc, Burlingto Terminated |
HBT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.