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 |