FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEPARIN COATED THERMODILUTION CATHETER
K Number: K821099
·
Decision May 18, 1982
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
3
Review Days
28
Basic Information
- Device Name
- HEPARIN COATED THERMODILUTION CATHETER
- K Number
- K821099
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- KMA, INC.
- Date Received
- April 20, 1982
- Decision Date
- May 18, 1982
- 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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