FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER
K Number: K140028
·
Decision Aug 21, 2014
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
14
Review Days
227
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Basic Information
- Device Name
- GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER
- K Number
- K140028
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Galt Medical Corp.
- Date Received
- January 6, 2014
- Decision Date
- August 21, 2014
- Product Code
- DYB
- 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 |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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