The following data is part of a premarket notification filed by Philips Volcano with the FDA for Pioneer Plus Catheter.
| Device ID | K162418 |
| 510k Number | K162418 |
| Device Name: | Pioneer Plus Catheter |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | PHILIPS VOLCANO 3721 VALLEY CENTRE DR, SUITE 500 San Diego, CA 92130 |
| Contact | Mary Stanners |
| Correspondent | Mary Stanners PHILIPS VOLCANO 3721 VALLEY CENTRE DR, SUITE 500 San Diego, CA 92130 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-30 |
| Decision Date | 2016-12-02 |
| Summary: | summary |