510(k) K080067 ยท MPA Endoilluminator
ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
| Applicant | Iscience Interventional, Menlo Park CA, US |
| Decision | Substantially Equivalent, Jul 18, 2008 |
| Received | Jan 10, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080067
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2018 | Ellex iScience, Inc. ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery. Terminated |
HMX | None listed |
| Sep 4, 2014 | Ellex iScience, Inc. iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile.
Indicated for fluid infusion and aspiration during surgery. Terminated |
HMX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.