Bipore, Inc.
Bipore, Inc. appears in FDA public data with 0 recalls, 10 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on April 1, 2008.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 10
- Inspections
- 7
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K073434 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | April 1, 2008 |
| K073318 | BIPORE BALLOON DILATION CATHETER | January 16, 2008 |
| K051513 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | December 7, 2005 |
| K041293 | BIOPORE BALLOON DILATION CATHETER | July 9, 2004 |
| K983650 | BIPORE BALLOON DILATATION CATHETER | February 17, 1999 |
| K973563 | BIPORE BALLOON DILATATION CATHETER | April 1, 1998 |
| K964814 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER | May 7, 1997 |
| K961980 | BIPORE BALLOON DILATATION CATHETER | September 12, 1996 |
| K862015 | O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER | July 22, 1986 |
| K844625 | BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY | January 16, 1985 |