The following data is part of a premarket notification filed by Porous Media Corp. with the FDA for Porous Media Dpb20 Series Disposable Pre-bypass Filter.
Device ID | K982385 |
510k Number | K982385 |
Device Name: | POROUS MEDIA DPB20 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 | 1998-07-09 |
Decision Date | 1999-02-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B462DPC2023S500C5 | K982385 | 000 |
B4624150002210 | K982385 | 000 |
B46200080020115 | K982385 | 000 |
B46200080020125 | K982385 | 000 |
B46200080020225 | K982385 | 000 |
B46200080020235 | K982385 | 000 |
B46200080020335 | K982385 | 000 |
B4623452900005 | K982385 | 000 |
B46261255 | K982385 | 000 |
B46261265 | K982385 | 000 |
B4627010543855 | K982385 | 000 |
B4624150002200 | K982385 | 000 |