FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
K Number: K141495
·
Decision Sep 3, 2014
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
62
Applicant Total
77
Review Days
89
Basic Information
- Device Name
- TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
- K Number
- K141495
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2870
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- Date Received
- June 6, 2014
- Decision Date
- September 3, 2014
- 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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