FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TruWave Disposable Pressure Transducer
K Number: K183413
·
Decision May 1, 2019
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
63
Applicant Total
3
Review Days
142
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Basic Information
- Device Name
- TruWave Disposable Pressure Transducer
- K Number
- K183413
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2870
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edwards Lifeciences, LLC
- Date Received
- December 10, 2018
- Decision Date
- May 1, 2019
- 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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Other Clearances by Edwards Lifeciences, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | Nov 7, 2022 | Substantially Equivalent |
| K183646 | Acumen Hypotension Prediction Index EV1000 Clinical Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index HemoSphere Advanced Monitoring Platform - Pressure | May 21, 2019 | Substantially Equivalent |