Company ยท US
Bipore, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2008. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 1, 2008 | K073434 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER Bipore, Inc. | DYB |
| Jan 16, 2008 | K073318 | BIPORE BALLOON DILATION CATHETER Bipore, Inc. | LIT |
| Dec 7, 2005 | K051513 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER Bipore, Inc. | DYB |
| Jul 9, 2004 | K041293 | BIOPORE BALLOON DILATION CATHETER Bipore, Inc. | LIT |
| Feb 17, 1999 | K983650 | BIPORE BALLOON DILATATION CATHETER Bipore, Inc. | LIT |
| Apr 1, 1998 | K973563 | BIPORE BALLOON DILATATION CATHETER Bipore, Inc. | LIT |
| May 7, 1997 | K964814 | BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER Bipore, Inc. | DYB |
| Sep 12, 1996 | K961980 | BIPORE BALLOON DILATATION CATHETER Bipore, Inc. | LIT |
| Jul 22, 1986 | K862015 | O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER Bipore, Inc. | FIB |
| Jan 16, 1985 | K844625 | BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY Bipore, Inc. | KOZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||