KRJ · Filter, Prebypass, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4280 · Class 2
Overview
| Product Code | KRJ |
|---|---|
| Device Name | Filter, Prebypass, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4280 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A cardiopulmonary prebypass filter is a device used during priming of the oxygenator circuit to remove particulates or other debris from the circuit prior to initiating bypass. The device is not used to filter blood.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K990276 | POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | Oct 1, 1999 | SESE |
| K982385 | POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER | Porous Media Corp. | Feb 1, 1999 | SESE |
| K940126 | AVECOR PRE-BYPASS FILTER | Avecor Cardiovascular, Inc. | Jun 28, 1994 | SESE |
| K900672 | PREBYPASS FILTER, CAT. NO. FPB-5 | American Omni Medical, Inc. | Apr 3, 1990 | SESE |
| K885154 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | Medtronic Blood Systems, Inc. | Feb 22, 1989 | SESE |
| K884390 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER | Medtronic Blood Systems, Inc. | Dec 21, 1988 | SESE |
| K884244 | INTERSEPT* PREBYPASS FILTER | Medtronic Blood Systems, Inc. | Dec 5, 1988 | SESE |
| K883086 | INTERSEPT*PREBYPASS FILTER | Medtronic Blood Systems, Inc. | Sep 16, 1988 | SESE |
| K875094 | ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | Feb 29, 1988 | SESE |
| K871350 | PREBYPASS FILTER | American Omni Medical, Inc. | Jun 8, 1987 | SESE |
| K861226 | INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 | Medical, Inc. | Jun 2, 1986 | SESE |
| K850139 | COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER | Rapid Diagnostic Laboratories, Inc. | Apr 10, 1985 | SESE |
| K842141 | SOLUTION CLARIFICATION UNIT | Pall Biomedical Products Co. | Aug 3, 1984 | SESE |
| K840450 | SHILEY PREBYPASS FILTER | Shiley, Inc. | Apr 17, 1984 | SESE |
| K832594 | PRE-BYPASS FILTER #EC-PBF SERIES | Gish Biomedical, Inc. | Sep 20, 1983 | SESE |
| K831286 | ULTIPORE PREBYPASS PLUS FILTER | Pall Biomedical Products Co. | Jun 8, 1983 | SESE |
| K812539 | PRE-BYPASS FILTER | Gelman Sciences, Inc. | Oct 13, 1981 | SESE |
| K812244 | INTERFACE PRE BYPASS PRIME FILTER #90 | Medical, Inc. | Aug 25, 1981 | SESE |
| K812240 | INTERFACE PRE BYPASS PRIME FILTER | Medical, Inc. | Aug 25, 1981 | SESE |
| K810395 | PRE-BYPASS FILTER | Texas Medical Products, Inc. | Mar 5, 1981 | SESE |
Top Applicants
- Medtronic Blood Systems, Inc. — 4 clearances
- Medical, Inc. — 3 clearances
- Pall Biomedical Products Co. — 3 clearances
- American Omni Medical, Inc. — 2 clearances
- Bentley Laboratories, Inc. — 2 clearances
