Creganna Medical Devices
FDA Regulatory Profile
Creganna Medical Devices appears in FDA public data with 5 recalls, 1 510(k) clearance, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2249-2023, Class II) was initiated on June 22, 2023. Its most recent 510(k) clearance was granted on August 1, 2013.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 1
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2249-2023 | Class II | Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access | June 22, 2023 |
| Z-2532-2017 | Class II | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Cat | May 22, 2017 |
| Z-2530-2017 | Class II | Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Cata | May 22, 2017 |
| Z-2531-2017 | Class II | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Cat | May 22, 2017 |
| Z-2529-2017 | Class II | Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Cat | May 22, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K131079 | CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC | August 1, 2013 |