CSA Medical, Inc.
Medical device manufacturer in Lexington, MA.
14510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K201183 | Vortex Radial Spray CatheterGEH · Traditional | 12/07/2020SE |
| K171626 | truFreeze SystemGEH · Traditional | 08/30/2017SE |
| K172041 | truFreeze SystemGEH · Special | 07/27/2017SE |
| K171522 | truFreeze Rapid AV Spray KitGEH · Traditional | 07/14/2017SE |
| K163244 | truFreeze SystemGEH · Traditional | 05/24/2017SE |
| K162695 | truFreeze SystemGEH · Special | 10/25/2016SE |
| K161557 | truFreeze SystemGEH · Traditional | 07/26/2016SE |
| K152668 | truFreeze SystemGEH · Special | 10/14/2015SE |
| K150920 | truFreeze SystemGEH · Traditional | 06/17/2015SE |
| K143625 | truFreeze SystemGEH · Special | 01/15/2015SE |
| K133258 | Trufreeze SystemGEH · Traditional | 06/19/2014SE |
| K113021 | Trufreeze System, Trufreeze Spray KitGEH · Traditional | 02/07/2012SE |
| K072651 | Cryospray Ablation System, Model CC2-NAMGEH · Abbreviated | 12/07/2007SE |
| K070893 | Cryospray Ablation System, Model Cu 8407020500GEH · Special | 05/01/2007SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1513-2015 Class II | CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may cause:… | 03/25/2015Terminated |
| Z-0941-2015 Class II | CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved…An increase in complaint trending for a loss of audible sound associated with the timer has been observed. | 11/10/2014Terminated |