FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
K Number: K140129
·
Decision Jul 2, 2014
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
18
Applicant Total
66
Review Days
167
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Basic Information
- Device Name
- PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
- K Number
- K140129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1230
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Icu Medical, Inc.
- Date Received
- January 16, 2014
- Decision Date
- July 2, 2014
- 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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