The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Dlp Silicone Coronary Artery Ostial Cannulae.
| Device ID | K141951 |
| 510k Number | K141951 |
| Device Name: | DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
| Contact | Kevin T Lam |
| Correspondent | Kevin T Lam MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, 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 | 2014-07-18 |
| Decision Date | 2014-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169454594 | K141951 | 000 |
| 20643169454600 | K141951 | 000 |
| 20643169454587 | K141951 | 000 |