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 |