FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Micro Ace Gold Advanced Micro Access System
K Number: K242229
·
Decision Jan 15, 2025
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
178
Review Days
169
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Basic Information
- Device Name
- Micro Ace Gold Advanced Micro Access System
- K Number
- K242229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merit Medical Systems, Inc.
- Date Received
- July 30, 2024
- Decision Date
- January 15, 2025
- 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 |
Similar 510(k) Clearances
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TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013)
FDA 510(k)
FDA Class 2
·Cardiovascular
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