AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
FDA 510(k) clearance K173762 · decided 2018-07-18
Clearance details
- K-number
- K173762
- Device name
- AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters
- Applicant
- AngioDynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-12-11
- Decision date
- 2018-07-18
- Days to decision
- 219 days
- Clearance type
- Special
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Queensburgy, NY, US
- Third-party review
- No
- Expedited review
- No
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