Cardima, Inc.
Medical device manufacturer in Fremont, CA.
12510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K060715 | Modification to: Cardima Ablation SystemOCL · Special | 05/15/2006SE |
| K022008 | Cardima Ablation SystemOCL · Traditional | 01/29/2003SE |
| K974683 | Naviport Deflectable Tip Guiding CatheterDQY · Traditional | 06/22/1999SE |
| K972803 | Tracer O-T-W Mapping DeviceDRF · Traditional | 05/11/1999SE |
| K982835 | Electrode Switchbox, Model 11-081002DRF · Abbreviated | 10/29/1998SE |
| K971975 | Cardima Pathfinder 1.5F Mapping MicrocatheterDRF · Traditional | 07/01/1998SE |
| K973298 | Cardima Vueport Coronary Sinus Balloon Occlusion Guiding CatheterDQY · Traditional | 06/26/1998SE |
| K970853 | Pathfinder 3MM Mapping Microcatheter (01-082001)DRF · Traditional | 11/04/1997SE |
| K955802 | PathfinderDRF · Traditional | 01/29/1997SE |
| K951603 | Cardima, Inc. ForerunnerDQY · Traditional | 10/05/1995SE |
| K932800 | Cardima Tracker(R) Infusion CatheterKRA · Traditional | 12/21/1993SE |
| K932801 | Cardima Seeker and Stubbie GuidewiresDQX · Traditional | 09/01/1993SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2581-2010 | Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device…Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could… | 05/20/2010Terminated |
| Z-2580-2010 | Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device…Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could… | 05/20/2010Terminated |