The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Omniwire Pressure Guide Wire, 185 Cm Straight Tip, Omniwire Pressure Guide Wire, 185 Cm J-tip.
| Device ID | K192886 |
| 510k Number | K192886 |
| Device Name: | OmniWire Pressure Guide Wire, 185 Cm Straight Tip, OmniWire Pressure Guide Wire, 185 Cm J-Tip |
| Classification | Blood Pressure Cuff |
| Applicant | Volcano Corporation 3721 Valley Centre Drive, Ste 500 San Diego, CA 92130 |
| Contact | Jenny Fu |
| Correspondent | Jenny Fu Volcano Corporation 3721 Valley Centre Drive, Ste 500 San Diego, CA 92130 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-10 |
| Decision Date | 2020-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845225003050 | K192886 | 000 |
| 00845225003043 | K192886 | 000 |