510(k) K081804 ยท PDU Catheter For Crossing Total Occlusions
PIONEER PLUS CATHETER
| Applicant | Medtronic, Inc., Santa Rosa CA, US |
| Decision | Substantially Equivalent, Aug 5, 2008 |
| Received | Jun 26, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081804
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2015 | Volcano Corporation Volcano Pioneer Plus Re-Entry Catheter;
Product Code PPLUS20, Catheter for Crossing Total Occlusions.
Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus Terminated |
PDU | None listed |
| Jan 6, 2011 | Medtronic CardioVascular Pioneer Plus Catheter PPlus 120 dual lumen device, inserted through a 6F introducer sheath and placed percutaneously into a peripheral vessel. The device tracks to its intended site in the vasculatur Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.