ANGIODYNAMICS, INC., MICRO ACCESS KITS
FDA 510(k) clearance K051655 · decided 2005-09-12
Clearance details
- K-number
- K051655
- Device name
- ANGIODYNAMICS, INC., MICRO ACCESS KITS
- Applicant
- AngioDynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-06-21
- Decision date
- 2005-09-12
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- DQR
- Device class
- 2
- Regulation number
- 870.1300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Queensburgy, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Stan recall (Z-1405-2013) | Angiodynamics, Inc. | 2013-05-25 |