510(k) K153530 ยท MJN Catheter, Intravascular Occluding, Temporary
Bridge Occlusion Balloon
| Applicant | Spectranetics, Inc., Colorado Springs CO, US |
| Decision | Substantially Equivalent, Feb 5, 2016 |
| Received | Dec 9, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153530
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2020 | Spectranetics Corporation Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guidewire Compatibility 0.035 in, Working Length 90 cm, Balloon Outer Diameter 31 mm, Balloon Length 80 mmm, Rx ONLY, CE Markin Terminated |
MJN | None listed |
| Aug 26, 2017 | Spectranetics Corporation Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only.
Product U Terminated |
MJN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.