510(k) K990276
- Device
- POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
- Applicant
- POROUS MEDIA CORP.
- 510(k) number
- K990276
- Product code
- KRJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-10-01
- Date received
- 1999-01-28
- Regulation
- 870.4280
- Classification name
- Filter, Prebypass, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROCHELLE M MICKSCHL
- Address
- 1350 Hammond Rd. St. Paul MN US 55110 55110
FDA Registration Numbers#
- 3006210673
- 2132517
- 3008132398
- 2029275
- 2011171
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KRJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K982385 | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | 1999-02-01 |
| K940126 | AVECOR PRE-BYPASS FILTER | Avecor Cardiovascular, Inc. | 1994-06-28 |
| K900672 | PREBYPASS FILTER, CAT. NO. FPB-5 | American Omni Medical, Inc. | 1990-04-03 |
| K885154 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | Medtronic Blood Systems, Inc. | 1989-02-22 |
| K884390 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER | Medtronic Blood Systems, Inc. | 1988-12-21 |
| K884244 | INTERSEPT* PREBYPASS FILTER | Medtronic Blood Systems, Inc. | 1988-12-05 |
| K883086 | INTERSEPT*PREBYPASS FILTER | Medtronic Blood Systems, Inc. | 1988-09-16 |
| K875094 | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | 1988-02-29 |
| K871350 | PREBYPASS FILTER | American Omni Medical, Inc. | 1987-06-08 |
| K861226 | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 | Medical, Inc. | 1986-06-02 |
| K850139 | COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER | Rapid Diagnostic Laboratories, Inc. | 1985-04-10 |
| K842141 | SOLUTION CLARIFICATION UNIT | Pall Biomedical Products Co. | 1984-08-03 |
| K840450 | SHILEY PREBYPASS FILTER | Shiley, Inc. | 1984-04-17 |
| K832594 | PRE-BYPASS FILTER #EC-PBF SERIES | Gish Biomedical, Inc. | 1983-09-20 |
| K831286 | ULTIPORE PREBYPASS PLUS FILTER | Pall Biomedical Products Co. | 1983-06-08 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases