The following data is part of a premarket notification filed by Vortex Medical Inc with the FDA for Vortex Medical Angiovac Cardiopulmonary Bypass Circuit.
| Device ID | K092486 |
| 510k Number | K092486 |
| Device Name: | VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT |
| Classification | Tubing, Pump, Cardiopulmonary Bypass |
| Applicant | VORTEX MEDICAL INC 42 HORICON AVE. Glens Falls, NY 12801 |
| Contact | Brian Kunst |
| Correspondent | Morten S Christensen UNDERWRITERS LABORATORIES, INC. 455 E. TRIMBLE ROAD San Jose, CA 95131 -1230 |
| Product Code | DWE |
| CFR Regulation Number | 870.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-08-13 |
| Decision Date | 2009-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965251830 | K092486 | 000 |