The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Affinity Pixie Oxygenation System With Carmeda Bioactive Surface Or Balance Biosurface.
Device ID | K100645 |
510k Number | K100645 |
Device Name: | AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
Contact | Jessica Sixberry |
Correspondent | Jessica Sixberry MEDTRONIC INC. 7611 NORTHLAND DRIVE Minneapolis, MN 55428 |
Product Code | DTZ |
Subsequent Product Code | DTN |
Subsequent Product Code | DTP |
Subsequent Product Code | DTR |
Subsequent Product Code | FLL |
Subsequent Product Code | JOD |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-03-05 |
Decision Date | 2012-09-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00613994803177 | K100645 | 000 |
20613994617310 | K100645 | 000 |
20613994617303 | K100645 | 000 |
20613994617273 | K100645 | 000 |
20613994617259 | K100645 | 000 |
20643169785803 | K100645 | 000 |