PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
FDA 510(k) clearance K140129 · decided 2014-07-02
Clearance details
- K-number
- K140129
- Device name
- PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
- Applicant
- Icu Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-16
- Decision date
- 2014-07-02
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- DQE
- Device class
- 2
- Regulation number
- 870.1230
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.