The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Revolution 45 Mhz Rotational Ivus Imaging Catheter.
| Device ID | K050995 |
| 510k Number | K050995 |
| Device Name: | REVOLUTION 45 MHZ ROTATIONAL IVUS IMAGING CATHETER |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Lorry Huffman |
| Correspondent | Lorry 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 | 2005-04-20 |
| Decision Date | 2005-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00184360000358 | K050995 | 000 |