The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Intracardiac Sump 12010.
Device ID | K850385 |
510k Number | K850385 |
Device Name: | INTRACARDIAC SUMP 12010 |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
Contact | Ronald A Williams |
Correspondent | Ronald A Williams 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 | 1985-02-01 |
Decision Date | 1985-04-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20613994619277 | K850385 | 000 |
20613994619260 | K850385 | 000 |
20613994619246 | K850385 | 000 |
20613994619239 | K850385 | 000 |
20613994619215 | K850385 | 000 |