FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Halo Single-Loop Microsnare Kit
K Number: K200963
·
Decision Jan 5, 2021
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
31
Applicant Total
20
Review Days
270
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Basic Information
- Device Name
- Halo Single-Loop Microsnare Kit
- K Number
- K200963
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Argon Medical Devices, Inc.
- Date Received
- April 10, 2020
- Decision Date
- January 5, 2021
- Product Code
- MMX
- 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 |
|---|---|---|---|
| MMX | Device, Percutaneous Retrieval | FDA class 2 | Cardiovascular |
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