The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Dlp Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring Line, Dlp Retrograde Coronary Sinus Perfusio.
Device ID | K132995 |
510k Number | K132995 |
Device Name: | DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
Contact | Chelsea Pioske |
Correspondent | Chelsea Pioske 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 | 2013-09-24 |
Decision Date | 2013-10-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20643169453177 | K132995 | 000 |