The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Shiley Vein Irrigation Cannula (beveled & Blunt).
| Device ID | K900753 |
| 510k Number | K900753 |
| Device Name: | SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT) |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Abati, Ph.d |
| Correspondent | Abati, Ph.d SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-16 |
| Decision Date | 1990-04-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10803622133104 | K900753 | 000 |
| 10803622133098 | K900753 | 000 |