FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE
K Number: K042996
·
Decision Nov 24, 2004
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
3
Review Days
23
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Basic Information
- Device Name
- COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE
- K Number
- K042996
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Volcano Therapeutics, Inc.
- Date Received
- November 1, 2004
- Decision Date
- November 24, 2004
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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