The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Dlp Coronary Ostial Perfusion Cannulae.
| Device ID | K131269 |
| 510k Number | K131269 |
| Device Name: | DLP CORONARY OSTIAL PERFUSION 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 | 2013-05-03 |
| Decision Date | 2013-07-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994576044 | K131269 | 000 |
| 20613994575955 | K131269 | 000 |
| 20613994575962 | K131269 | 000 |
| 20613994575979 | K131269 | 000 |
| 20613994575986 | K131269 | 000 |
| 20613994575993 | K131269 | 000 |
| 20613994576006 | K131269 | 000 |
| 20613994576013 | K131269 | 000 |
| 20613994576020 | K131269 | 000 |
| 20613994576037 | K131269 | 000 |
| 20613994575948 | K131269 | 000 |