FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PressureWire X
K Number: K180558
·
Decision Mar 28, 2018
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
63
Applicant Total
1
Review Days
27
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Basic Information
- Device Name
- PressureWire X
- K Number
- K180558
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2870
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- St. Jude Medical (Now Part of Abbott Medical)
- Date Received
- March 1, 2018
- Decision Date
- March 28, 2018
- Product Code
- DXO
- 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 |
|---|---|---|---|
| DXO | Transducer, Pressure, Catheter Tip | FDA class 2 | Cardiovascular |
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