FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Swan-Ganz catheter
K Number: K233824
·
Decision Jun 6, 2024
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
98
Applicant Total
136
Review Days
188
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Basic Information
- Device Name
- Swan-Ganz catheter
- K Number
- K233824
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edwards Lifesciences, LLC
- Date Received
- December 1, 2023
- Decision Date
- June 6, 2024
- Product Code
- DYG
- 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 |
|---|---|---|---|
| DYG | Catheter, Flow Directed | FDA class 2 | Cardiovascular |
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