FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
K Number: K033424
·
Decision Dec 11, 2003
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
16
Review Days
49
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Basic Information
- Device Name
- ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
- K Number
- K033424
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Transonic Systems, Inc.
- Date Received
- October 23, 2003
- Decision Date
- December 11, 2003
- Product Code
- DPW
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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