FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DeRoyal Angiography Kits
K Number: K152978
·
Decision Mar 25, 2016
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
209
Applicant Total
91
Review Days
168
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Basic Information
- Device Name
- DeRoyal Angiography Kits
- K Number
- K152978
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Deroyal Industries, Inc.
- Date Received
- October 9, 2015
- Decision Date
- March 25, 2016
- Product Code
- DXT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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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