FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
K Number: K192370
·
Decision Dec 13, 2019
Classifications
1
FEI Numbers
120
Registration Numbers
120
Same Product Code
204
Applicant Total
1
Review Days
105
Basic Information
- Device Name
- MEDRAD Stellant FLEX CT Injection System with Certegra Workstation
- K Number
- K192370
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Medical Care, Inc.
- Date Received
- August 30, 2019
- Decision Date
- December 13, 2019
- Product Code
- DXT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
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