The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Sw V3.5 Install Kit, Core Mobile, Sw V3.5 Install Kit, Core, Sw V3.5 Install Kit, S5iz.
| Device ID | K153369 |
| 510k Number | K153369 |
| Device Name: | SW V3.5 Install Kit, CORE Mobile, SW V3.5 Install Kit, CORE, SW V3.5 Install Kit, S5iz |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VOLCANO CORPORATION 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Contact | Brian Park |
| Correspondent | Brian Park VOLCANO CORPORATION 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Product Code | IYO |
| Subsequent Product Code | DSA |
| Subsequent Product Code | DSK |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-23 |
| Decision Date | 2015-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225012823 | K153369 | 000 |
| 00845225012724 | K153369 | 000 |
| 00845225012779 | K153369 | 000 |