The following data is part of a premarket notification filed by Volcano Therapeutics, Inc. with the FDA for Combomap Pressure And Flow System.
| Device ID | K041134 |
| 510k Number | K041134 |
| Device Name: | COMBOMAP PRESSURE AND FLOW SYSTEM |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | VOLCANO THERAPEUTICS, INC. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Lorry W Huffman |
| Correspondent | Lorry W Huffman VOLCANO THERAPEUTICS, INC. 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 | 2004-04-30 |
| Decision Date | 2004-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00084522501874 | K041134 | 000 |
| 00845225010874 | K041134 | 000 |