ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
FDA 510(k) clearance K030415 · decided 2003-04-30
Clearance details
- K-number
- K030415
- Device name
- ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
- Applicant
- AngioDynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-02-07
- Decision date
- 2003-04-30
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Queensburgy, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, recall (Z-0467-2012) | Angiodynamics Worldwide Headquarters | 2012-01-11 |