FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
K Number: K924661
·
Decision Apr 8, 1993
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
170
Applicant Total
503
Review Days
205
Basic Information
- Device Name
- SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
- K Number
- K924661
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BAXTER HEALTHCARE CORP.
- Date Received
- September 15, 1992
- Decision Date
- April 8, 1993
- Product Code
- KRA
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
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