The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Dlp Retrograde Coronary Sinus Perfusion Cannula With Auto-inflate Cuff.
| Device ID | K123762 |
| 510k Number | K123762 |
| Device Name: | DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC INC. 7611 NORTHLAND DR. Brooklyn Park, MN 55428 |
| Contact | Chelsea Pioske |
| Correspondent | Chelsea Pioske MEDTRONIC INC. 7611 NORTHLAND DR. Brooklyn Park, MN 55428 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-07 |
| Decision Date | 2013-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169454860 | K123762 | 000 |
| 20643169454853 | K123762 | 000 |
| 20643169454761 | K123762 | 000 |
| 20643169454754 | K123762 | 000 |
| 20643169454419 | K123762 | 000 |
| 20643169454402 | K123762 | 000 |
| 20613994575597 | K123762 | 000 |