CSA Medical
FDA Regulatory Profile
CSA Medical appears in FDA public data with 2 recalls, 14 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1513-2015, Class II) was initiated on Mar 25, 2015. Its most recent 510(k) clearance was granted on Dec 7, 2020.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 14
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1513-2015 | Class II | CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01 | Mar 25, 2015 |
| Z-0941-2015 | Class II | CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved units ar | Nov 10, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201183 | Vortex Radial Spray Catheter | Dec 7, 2020 |
| K171626 | truFreeze System | Aug 30, 2017 |
| K172041 | truFreeze System | Jul 27, 2017 |
| K171522 | truFreeze Rapid AV Spray Kit | Jul 14, 2017 |
| K163244 | truFreeze System | May 24, 2017 |
| K162695 | truFreeze System | Oct 25, 2016 |
| K161557 | truFreeze System | Jul 26, 2016 |
| K152668 | truFreeze System | Oct 14, 2015 |
| K150920 | truFreeze System | Jun 17, 2015 |
| K143625 | truFreeze System | Jan 15, 2015 |
| K133258 | TRUFREEZE SYSTEM | Jun 19, 2014 |
| K113021 | TRUFREEZE SYSTEM, TRUFREEZE SPRAY KIT | Feb 7, 2012 |
| K072651 | CRYOSPRAY ABLATION SYSTEM, MODEL CC2-NAM | Dec 7, 2007 |
| K070893 | CRYOSPRAY ABLATION SYSTEM, MODEL CU 8407020500 | May 1, 2007 |