The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Arterial Cannula Curved Beveled Tip.
Device ID | K840002 |
510k Number | K840002 |
Device Name: | ARTERIAL CANNULA CURVED BEVELED TIP |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
Contact | James Devries |
Correspondent | James Devries DLP, INC. 620 WATSON S.W., 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 | 1984-01-03 |
Decision Date | 1984-02-13 |