510(k) K152090 ยท PNE Reprocessed Catheter Introducer
Reprocessed Steerable Introducer
| Applicant | Sterilmed, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Mar 23, 2016 |
| Received | Jul 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152090
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2018 | Sterilmed, Inc. Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart.
(a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309;
(b) me Terminated |
PNH | None listed |
| Dec 29, 2017 | Sterilmed Inc St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single u Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.