The following data is part of a premarket notification filed by Medline, Industries, Inc. with the FDA for Medline Vessel Cannula.
Device ID | K111147 |
510k Number | K111147 |
Device Name: | MEDLINE VESSEL CANNULA |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MEDLINE, INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
Contact | Matt Clausen |
Correspondent | Matt Clausen MEDLINE, INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-25 |
Decision Date | 2011-07-19 |
Summary: | summary |