The following data is part of a premarket notification filed by Volcano Corporation with the FDA for S5/s5i Series Intravascular Imaging And Pressure System, Combomap Pressure And Flow System.
| Device ID | K082229 |
| 510k Number | K082229 |
| Device Name: | S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Mamta Vats |
| Correspondent | Mamta Vats VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-07 |
| Decision Date | 2008-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225011765 | K082229 | 000 |