FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VSI StraitSet micro-introducer kit
K Number: K161336
·
Decision Aug 11, 2016
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
103
Review Days
90
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Basic Information
- Device Name
- VSI StraitSet micro-introducer kit
- K Number
- K161336
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vascular Solutions, Inc.
- Date Received
- May 13, 2016
- Decision Date
- August 11, 2016
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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