KRJClass II
Filter, Prebypass, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4280
MDR events3All time
Recalls0All time
Registered firms7Currently listed
510(k) clearances24All time
Recent MDR events
3 adverse event reports on file
Event type breakdown
Unspecified2
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
510(k) clearances
24 clearances for this product code
- Porous Media Corp.Oct 1, 1999
K990276 · POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
- Porous Media Corp.Feb 1, 1999
K982385 · POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
- Avecor Cardiovascular, Inc.Jun 28, 1994
K940126 · AVECOR PRE-BYPASS FILTER
- American Omni Medical, Inc.Apr 3, 1990
K900672 · PREBYPASS FILTER, CAT. NO. FPB-5
- Medtronic Blood Systems, Inc.Feb 22, 1989
K885154 · INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM
- Medtronic Blood Systems, Inc.Dec 21, 1988
K884390 · INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER
- Medtronic Blood Systems, Inc.Dec 5, 1988
K884244 · INTERSEPT* PREBYPASS FILTER
- Medtronic Blood Systems, Inc.Sep 16, 1988
K883086 · INTERSEPT*PREBYPASS FILTER