Onset Medical Corporation
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K152498 | SoloPath Re-Collapsible Access System | January 5, 2016 |
| K121404 | SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM | May 3, 2013 |
| K112629 | ONSET ACCESS CATHETER SYSTEM | October 11, 2011 |
| K100819 | THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER | August 2, 2010 |
| K092014 | SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER | October 8, 2009 |
| K062852 | BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870 | February 23, 2007 |
| K061009 | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS | May 2, 2006 |
| K043254 | PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH | February 10, 2005 |