The following data is part of a premarket notification filed by Volcano Therapeutics, Inc. with the FDA for Combowire Pressure And Flow Guide Wire, Combotip Pressure And Flow Guide Wire.
| Device ID | K042996 |
| 510k Number | K042996 |
| Device Name: | COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | VOLCANO THERAPEUTICS, INC. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Lorry Huffman |
| Correspondent | Lorry Huffman VOLCANO THERAPEUTICS, INC. 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2004-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00184360000341 | K042996 | 000 |
| 00184360000334 | K042996 | 000 |