FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
MagiCath II
K Number: K210929
·
Decision Sep 13, 2022
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
1
Review Days
533
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Basic Information
- Device Name
- MagiCath II
- K Number
- K210929
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Woo Young Medical Co., Ltd.
- Date Received
- March 29, 2021
- Decision Date
- September 13, 2022
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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