The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Volcano S5/s5i Intravascular Imaging And Pressure System.
| Device ID | K071554 |
| 510k Number | K071554 |
| Device Name: | VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Lorry W Huffman |
| Correspondent | Lorry W Huffman VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-07 |
| Decision Date | 2008-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00184360000709 | K071554 | 000 |
| 00845225010218 | K071554 | 000 |
| 00845225010232 | K071554 | 000 |
| 00845225010317 | K071554 | 000 |
| 00845225010935 | K071554 | 000 |
| 00845225011093 | K071554 | 000 |
| 00845225011109 | K071554 | 000 |
| 00845225011239 | K071554 | 000 |
| 00845225011420 | K071554 | 000 |
| 00845225012038 | K071554 | 000 |
| 00845225012045 | K071554 | 000 |
| 00845225012304 | K071554 | 000 |
| 00845225012588 | K071554 | 000 |
| 00845225012595 | K071554 | 000 |
| 00845225012755 | K071554 | 000 |
| 00845225012762 | K071554 | 000 |
| 00184360000525 | K071554 | 000 |
| 00184360000686 | K071554 | 000 |
| 00845225010195 | K071554 | 000 |