The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Aortic Root Cannula W/integral Press.
Device ID | K831591 |
510k Number | K831591 |
Device Name: | AORTIC ROOT CANNULA W/INTEGRAL PRESS |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | DLP, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-05-17 |
Decision Date | 1983-06-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20613994918608 | K831591 | 000 |
20613994918585 | K831591 | 000 |
20613994900412 | K831591 | 000 |
20613994540090 | K831591 | 000 |
20613994495420 | K831591 | 000 |