The following data is part of a premarket notification filed by Rand S.r.l. with the FDA for Medtronic Performer Tm Cpb, Model R51, Pcpb.
Device ID | K052555 |
510k Number | K052555 |
Device Name: | MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB |
Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
Applicant | RAND S.R.L. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
Contact | Preeti Jain |
Correspondent | Preeti Jain RAND S.R.L. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
Product Code | DTQ |
CFR Regulation Number | 870.4220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-09-16 |
Decision Date | 2006-03-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613994160638 | K052555 | 000 |
00885074514857 | K052555 | 000 |