FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
K Number: K110167
·
Decision Feb 18, 2011
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
18
Applicant Total
136
Review Days
29
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Basic Information
- Device Name
- PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
- K Number
- K110167
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1230
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edwards Lifesciences, LLC
- Date Received
- January 20, 2011
- Decision Date
- February 18, 2011
- Product Code
- DQE
- 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 |
|---|---|---|---|
| DQE | Catheter, Oximeter, Fiber-Optic | FDA class 2 | Cardiovascular |
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