The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Retrograde Coronary Sinus Perfusion Cannula With No Pressure Line (15 French, Manual And Auto Inflate).
| Device ID | K030696 |
| 510k Number | K030696 |
| Device Name: | RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH NO PRESSURE LINE (15 FRENCH, MANUAL AND AUTO INFLATE) |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. N Minneapolis, MN 55428 |
| Contact | Preeti Jain |
| Correspondent | Preeti Jain MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. N 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 | 2003-03-06 |
| Decision Date | 2003-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169087037 | K030696 | 000 |
| 20613994457299 | K030696 | 000 |