The following data is part of a premarket notification filed by Advocacy International, Ltd. with the FDA for Flowguard Catheters & Cannalae.
| Device ID | K813037 |
| 510k Number | K813037 |
| Device Name: | FLOWGUARD CATHETERS & CANNALAE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | ADVOCACY INTERNATIONAL, LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-28 |
| Decision Date | 1981-12-14 |