American Catheter Corp
FDA Regulatory Profile
American Catheter Corp appears in FDA public data with 1 recall, 1 510(k) clearance, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2191-2015, Class II) was initiated on March 17, 2015. Its most recent 510(k) clearance was granted on August 9, 1994.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2191-2015 | Class II | American Catheter / Cholangiogram Catheter 9100 Series. | March 17, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K942335 | ACI SILICATH THORACIC CATHETER | August 9, 1994 |