Cardiovascular Imaging Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 19
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K970049 | BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER | June 20, 1997 |
| K942231 | MICROVIEW II/MICRORAIL II CATHETERS | August 1, 1994 |
| K933517 | AUTOMATIC PULL BACK DEVICE | October 15, 1993 |
| K930232 | CVIS INSIGHT IMAGING GUIDE CATHETER | July 21, 1993 |
| K924922 | CVIS INSIGHT IMAGING CATHETER | June 29, 1993 |
| K930311 | CVIS LONGVIEW | June 2, 1993 |
| K921879 | CBIS CATHETER PULL-BACK DEVICE | July 16, 1992 |
| K921750 | CVIS INSIGHT III SYSTEM | July 13, 1992 |
| K921631 | CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL | July 2, 1992 |
| K921147 | CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL USE | June 16, 1992 |
| K921148 | CVIS INSIGHT CATHETERS FOR INTRACARDIAC USE | June 16, 1992 |
| K911414 | CVIS INSIGHT IMAGING CATHETERS | September 11, 1991 |
| K904618 | CVIS INSIGHT IMAGING CATHETER | April 12, 1991 |
| K905625 | CVIS INSIGHT IMAGING CATHETER | February 21, 1991 |
| K901562 | CVIS INSIGHT IMAGING CATHETER | July 9, 1990 |
| K901691 | CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE | July 6, 1990 |
| K897153 | CVIS INSIGHT IMAGING CATHETER | March 26, 1990 |
| K893837 | CVIS ULTRA-SCAN ONE IMAGING CATHETER | August 22, 1989 |
| K891386 | CVIS ULTRA-SCAN ONE IMAGING SYSTEM | May 16, 1989 |