The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Mircsp (minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula, Model 94113td.
| Device ID | K090869 |
| 510k Number | K090869 |
| Device Name: | MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55432 |
| Contact | Jessica Sixberry |
| Correspondent | Jessica Sixberry MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55432 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-31 |
| Decision Date | 2009-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169086962 | K090869 | 000 |
| 20643169086221 | K090869 | 000 |
| 20643169086214 | K090869 | 000 |
| 20643169086207 | K090869 | 000 |