FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VSI Micro-Introducer Kit
K Number: K180913
·
Decision May 9, 2018
Classifications
1
FEI Numbers
268
Registration Numbers
268
Same Product Code
682
Applicant Total
14
Review Days
30
Basic Information
- Device Name
- VSI Micro-Introducer Kit
- K Number
- K180913
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vascular Solutions, Inc.
- Date Received
- April 9, 2018
- Decision Date
- May 9, 2018
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
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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