The following data is part of a premarket notification filed by Vortex Medical Inc with the FDA for Angiovac Cannula.
| Device ID | K133445 |
| 510k Number | K133445 |
| Device Name: | ANGIOVAC CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | VORTEX MEDICAL INC 26 FOREST ST. Marlborough, MA 01752 |
| Contact | Lorraine M Hanley |
| Correspondent | Lorraine M Hanley VORTEX MEDICAL INC 26 FOREST ST. Marlborough, MA 01752 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-12 |
| Decision Date | 2014-03-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965251840 | K133445 | 000 |