510(k) K031623 ยท FZP Clip, Implantable
MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
| Applicant | Coalescent Surgical, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 3, 2003 |
| Received | May 23, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031623
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2010 | Medtronic Cardiovascular Revascularization & Surgical Therap Medtronic U-CLIP Double Arm Approximation Device, model V100D U-Clip, Catalog Number V100DRFRN2. Sterilized using Irradiation. The U-Clip consists of specially designed vascular clips optionally con Terminated |
FZP | None listed |
| Sep 16, 2008 | Medtronic Cardiac Surgery Technologies VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices. Terminated |
FZP | None listed |
| Jun 27, 2007 | Medtronic Cardiac Surgery Technologies Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices. Terminated |
FZP | None listed |
| Apr 13, 2006 | Medtronic Cardiac Surgery Technologies Medtronic SPYDER Anastomotic Device. Sterilized using irradiation. Do not Reuse. Nonpyrogenic. The SPYDER is designed to create an anastomosis in a rapid, automated fashion. The device creates an Terminated |
FZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.