The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Descending Arch Cannula.
Device ID | K880421 |
510k Number | K880421 |
Device Name: | DESCENDING ARCH CANNULA |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Contact | Van Hof |
Correspondent | Van Hof DLP, INC. P.O.BOX 409 620 WATSONS S.W. 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 | 1988-02-01 |
Decision Date | 1988-04-28 |