FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
K Number: K001063
·
Decision Jul 7, 2000
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
98
Applicant Total
505
Review Days
95
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Basic Information
- Device Name
- SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
- K Number
- K001063
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Baxter Healthcare Corp
- Date Received
- April 3, 2000
- Decision Date
- July 7, 2000
- 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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