FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101
K Number: K010253
·
Decision Mar 19, 2002
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
98
Applicant Total
16
Review Days
417
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Basic Information
- Device Name
- ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101
- K Number
- K010253
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1240
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Transonic Systems, Inc.
- Date Received
- January 26, 2001
- Decision Date
- March 19, 2002
- 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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