Company ยท US
CSA Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2020. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 16 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 7, 2020 | K201183 | Vortex Radial Spray Catheter CSA Medical, Inc. | GEH |
| Aug 30, 2017 | K171626 | truFreeze System CSA Medical, Inc. | GEH |
| Jul 27, 2017 | K172041 | truFreeze System CSA Medical, Inc. | GEH |
| Jul 14, 2017 | K171522 | truFreeze Rapid AV Spray Kit CSA Medical, Inc. | GEH |
| May 24, 2017 | K163244 | truFreeze System CSA Medical, Inc. | GEH |
| Oct 25, 2016 | K162695 | truFreeze System CSA Medical, Inc. | GEH |
| Jul 26, 2016 | K161557 | truFreeze System CSA Medical, Inc. | GEH |
| Oct 14, 2015 | K152668 | truFreeze System CSA Medical, Inc. | GEH |
| Jun 17, 2015 | K150920 | truFreeze System CSA Medical, Inc. | GEH |
| Jan 15, 2015 | K143625 | truFreeze System CSA Medical, Inc. | GEH |
| Jun 19, 2014 | K133258 | TRUFREEZE SYSTEM CSA Medical, Inc. | GEH |
| Feb 7, 2012 | K113021 | TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT CSA Medical, Inc. | GEH |
| Dec 7, 2007 | K072651 | CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM CSA Medical, Inc. | GEH |
| May 1, 2007 | K070893 | CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 CSA Medical, Inc. | GEH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2015 | CSA Medical CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device
Model: CC3-01 Terminated |
GEH | K143625 |
| Jan 7, 2015 | CSA Medical CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device
***The involved units are those with the newest version of a panel PC referred to as POC-127. These panels are identified by Terminated |
GEH | K133258 |