510(k) K141516 ยท NRY Catheter, Thrombus Retriever
MINDFRAME CAPTURE LP REVASCULARIZATION DEVICE
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, Irvine CA, US |
| Decision | Substantially Equivalent, Feb 5, 2015 |
| Received | Jun 9, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141516
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2018 | Micro Therapeutics Inc, Dba Ev3 Neurovascular MindFrame Capture LP Revascularization Devices: Product Numbers:
(a) REF 300010
(b) REF 300011
(c) REF 300012
(d) REF 300013
(e) REF 300014
(f) REF 300015
(g) REF 300016
(h) REF 300017
(i) REF 30001 Terminated |
NRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.