510(k) K151396 ยท DQY Catheter, Percutaneous
MIVI Mi-AXUS Guide Catheter
| Applicant | Mivi Neuroscience, Inc., Eden Prarie MN, US |
| Decision | Substantially Equivalent, Dec 9, 2015 |
| Received | May 26, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151396
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2021 | Mivi Neuroscience Inc MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile.
Device i Terminated |
DQY | None listed |
| Jul 23, 2021 | Mivi Neuroscience Inc MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only.
Device is use Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.