The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Pioneer Plus Catheter, Model Plus 120.
| Device ID | K101777 |
| 510k Number | K101777 |
| Device Name: | PIONEER PLUS CATHETER, MODEL PLUS 120 |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | MEDTRONIC VASCULAR 3576 Unocal Place Santa Rosa, CA 95403 |
| Contact | Lucinda L Fox |
| Correspondent | Lucinda L Fox MEDTRONIC VASCULAR 3576 Unocal Place Santa Rosa, CA 95403 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-25 |
| Decision Date | 2010-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225002565 | K101777 | 000 |