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 |