The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Madtronic Dlp Arterial Cannulae.
| Device ID | K991066 |
| 510k Number | K991066 |
| Device Name: | MADTRONIC DLP ARTERIAL CANNULAE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC VASCULAR 620 WATSON,SW P.O.BOX 409 Grand Rapids, MI 49501 |
| Contact | James Balun |
| Correspondent | James Balun MEDTRONIC VASCULAR 620 WATSON,SW P.O.BOX 409 Grand Rapids, MI 49501 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-31 |
| Decision Date | 1999-09-14 |
| Summary: | summary |