The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Dlp Vein Graft Cannula.
Device ID | K143107 |
510k Number | K143107 |
Device Name: | DLP Vein Graft Cannula |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MEDTRONIC, INC. 7611 NORTHLAND DRIVE Brooklyn Park, MN 55428 |
Contact | Kevin Lam |
Correspondent | Kevin Lam MEDTRONIC, INC. 7611 NORTHLAND DRIVE Brooklyn Park, MN 55428 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-29 |
Decision Date | 2015-01-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20643169881321 | K143107 | 000 |