The following data is part of a premarket notification filed by Vortex Medical Inc with the FDA for Vortex Cannula.
| Device ID | K091304 |
| 510k Number | K091304 |
| Device Name: | VORTEX CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | VORTEX MEDICAL INC 50 LORING DRIVE Norwell, MA 02061 |
| Contact | Cheryl Blake |
| Correspondent | Morten Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-05-04 |
| Decision Date | 2009-07-02 |
| Summary: | summary |