510(k) K101777 ยท PDU Catheter For Crossing Total Occlusions
PIONEER PLUS CATHETER, MODEL PLUS 120
| Applicant | Medtronic Vascular, Santa Rosa CA, US |
| Decision | Substantially Equivalent, Jul 23, 2010 |
| Received | Jun 25, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101777
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.