The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Core M2 Vascular System.
| Device ID | K170385 |
| 510k Number | K170385 |
| Device Name: | CORE M2 Vascular System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Volcano Corporation 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Contact | Courtney Moore |
| Correspondent | Courtney Moore Volcano Corporation 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-08 |
| Decision Date | 2017-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225012786 | K170385 | 000 |
| 00845225012717 | K170385 | 000 |
| 00845225012663 | K170385 | 000 |