Coapt Systems, Inc.
Palo Alto, CA, US
Coapt Systems, Inc. appears in FDA device records in Palo Alto, CA. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Coapt Systems, Inc. between 2002 and 2009. The busiest year on record is 2004, with 4. The most recent is 2009, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 4 |
| 2005 | 2 |
| 2006 | 3 |
| 2008 | 2 |
| 2009 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K083783 | VF LIQUIGEL | MIX | Substantially Equivalent | |
| K080956 | MODIFICATION TO VF GEL PLUS | MIX | Substantially Equivalent | |
| K071663 | VF GEL PLUS | MIX | Substantially Equivalent | |
| K060249 | ULTRATINE FOREHEAD | HWC | Substantially Equivalent | |
| K060248 | ULTRATINE TRANSBLEPH | HWC | Substantially Equivalent | |
| K060828 | MODIFICATION TO ENDOTINE RIBBON | GAM | Substantially Equivalent | |
| K051415 | ENDOTINE RIBBON | GAM | Substantially Equivalent | |
| K050611 | ENDOTINE RIBBON | GAM | Substantially Equivalent | |
| K042796 | ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE | HWC | Substantially Equivalent | |
| K041835 | ENDOTINE MIDFACE B 4.5 DEVICE | HWC | Substantially Equivalent | |
| K042078 | ENDOTINE FOREHEAD TRIPLE DEVICE | HWC | Substantially Equivalent | |
| K040740 | ENDOTINE TRANSBLEPH DEVICE | HWC | Substantially Equivalent | |
| K033524 | COAPT ENDOTINE CHIN 3.5 DEVICE | HWC | Substantially Equivalent | |
| K032698 | COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE | GAM | Substantially Equivalent | |
| K032770 | ENDOTINE FOREHEAD DEVICE | HWC | Substantially Equivalent | |
| K023922 | COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 | HWC | Substantially Equivalent | |
| K014153 | COAPT SYSTMES ENDOTINE DEVICE | HWC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1002-03 | Drill bits used in ENDOTINE Forehead 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303 | During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain