The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Primewire Prestiage Pressure Guide Wire, Models 8185, 8185j, 8300, 8300j.
| Device ID | K100930 |
| 510k Number | K100930 |
| Device Name: | PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J |
| Classification | Wire, Guide, Catheter |
| Applicant | VOLCANO CORPORATION 3661 VALLEY CENTER DR SUITE 200 San Diego, CA 92130 |
| Contact | Marilyn Pourazar |
| Correspondent | Marilyn Pourazar VOLCANO CORPORATION 3661 VALLEY CENTER DR SUITE 200 San Diego, CA 92130 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-05 |
| Decision Date | 2010-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225001179 | K100930 | 000 |
| 00845225001162 | K100930 | 000 |
| 00845225001155 | K100930 | 000 |
| 00845225001148 | K100930 | 000 |