The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Reflow Aspiration Catheter.
| Device ID | K123482 |
| 510k Number | K123482 |
| Device Name: | REFLOW ASPIRATION CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | VOLCANO CORPORATION 3661 VALLEY CENTER DR SUITE 200 San Diego, CA 92130 |
| Contact | Brian Park |
| Correspondent | Brian Park VOLCANO CORPORATION 3661 VALLEY CENTER DR SUITE 200 San Diego, CA 92130 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-13 |
| Decision Date | 2013-04-29 |
| Summary: | summary |