Company ยท US
Coapt Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2009. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2009 | K083783 | VF LIQUIGEL Coapt Systems, Inc. | MIX |
| Apr 25, 2008 | K080956 | MODIFICATION TO VF GEL PLUS Coapt Systems, Inc. | MIX |
| Feb 15, 2008 | K071663 | VF GEL PLUS Coapt Systems, Inc. | MIX |
| Jun 12, 2006 | K060249 | ULTRATINE FOREHEAD Coapt Systems, Inc. | HWC |
| Jun 12, 2006 | K060248 | ULTRATINE TRANSBLEPH Coapt Systems, Inc. | HWC |
| Apr 19, 2006 | K060828 | MODIFICATION TO ENDOTINE RIBBON Coapt Systems, Inc. | GAM |
| Jun 23, 2005 | K051415 | ENDOTINE RIBBON Coapt Systems, Inc. | GAM |
| Apr 6, 2005 | K050611 | ENDOTINE RIBBON Coapt Systems, Inc. | GAM |
| Nov 5, 2004 | K042796 | ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE Coapt Systems, Inc. | HWC |
| Sep 28, 2004 | K041835 | ENDOTINE MIDFACE B 4.5 DEVICE Coapt Systems, Inc. | HWC |
| Aug 27, 2004 | K042078 | ENDOTINE FOREHEAD TRIPLE DEVICE Coapt Systems, Inc. | HWC |
| May 10, 2004 | K040740 | ENDOTINE TRANSBLEPH DEVICE Coapt Systems, Inc. | HWC |
| Dec 18, 2003 | K033524 | COAPT ENDOTINE CHIN 3.5 DEVICE Coapt Systems, Inc. | HWC |
| Oct 23, 2003 | K032698 | COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE Coapt Systems, Inc. | GAM |
| Oct 8, 2003 | K032770 | ENDOTINE FOREHEAD DEVICE Coapt Systems, Inc. | HWC |
| Dec 20, 2002 | K023922 | COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 Coapt Systems, Inc. | HWC |
| Mar 15, 2002 | K014153 | COAPT SYSTMES ENDOTINE DEVICE Coapt Systems, Inc. | HWC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2003 | Coapt Systems, Inc. Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303 Terminated |
--- | None listed |