SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS
FDA 510(k) clearance K081472 · decided 2008-09-23
Clearance details
- K-number
- K081472
- Device name
- SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS
- Applicant
- AngioDynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-05-27
- Decision date
- 2008-09-23
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- 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 |
|---|---|---|
| SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics Incorporated The S recall (Z-1898-2009) | Angiodynamics, INC | 2009-09-01 |