The following data is part of a premarket notification filed by Porous Media Corp. with the FDA for Porous Media Dpb30 Series Disposable Pre-bypass Filter.
Device ID | K990276 |
510k Number | K990276 |
Device Name: | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER |
Classification | Filter, Prebypass, Cardiopulmonary Bypass |
Applicant | POROUS MEDIA CORP. 1350 HAMMOND RD. St. Paul, MN 55110 |
Contact | Rochelle M Mickschl |
Correspondent | Rochelle M Mickschl POROUS MEDIA CORP. 1350 HAMMOND RD. St. Paul, MN 55110 |
Product Code | KRJ |
CFR Regulation Number | 870.4280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-01-28 |
Decision Date | 1999-10-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B462DPB3032PES002YV5 | K990276 | 000 |
B46210210403 | K990276 | 000 |
B46210210393 | K990276 | 000 |
B4620302183 | K990276 | 000 |
B4620170169025 | K990276 | 000 |
B4620170169013 | K990276 | 000 |
B4620170169005 | K990276 | 000 |
B4620008810893 | K990276 | 000 |
B4620008038383 | K990276 | 000 |
B4620008038123 | K990276 | 000 |
B4620008012125 | K990276 | 000 |
B46210310843 | K990276 | 000 |
B46210310863 | K990276 | 000 |
B4623452600003 | K990276 | 000 |
B462DPB3032PES002YN3 | K990276 | 000 |
B462DPB3022PES002YN3 | K990276 | 000 |
B462DPB30223 | K990276 | 000 |
B4627010310863 | K990276 | 000 |
B4627010310843 | K990276 | 000 |
B4627010210403 | K990276 | 000 |
B4627010210393 | K990276 | 000 |
B4624724230000013 | K990276 | 000 |
B4623452800003 | K990276 | 000 |
B4623452700003 | K990276 | 000 |
B462DPB3033PES002YN0 | K990276 | 000 |