Piccox Peripherally Inserted Pressure Injectable Central Venous Oximetry Catheter
510(k) K140129
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140129 | Date2 Jul 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQE
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1230
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Piccox Peripherally Inserted Pressure Injectable Central Venous Oximetry Catheter is a fiber-optic oximeter catheter designed for central venous access. It enables continuous in vivo measurement of central venous oxygen saturation (ScvO₂) while facilitating intravenous therapy, blood sampling, and pressure injection of contrast media.
This device is intended for single-use in clinical settings and is supplied sterile. It is classified as a Class II medical device under FDA regulations (870.1230) and has received a Traditional 510(k) clearance via the Cardiovascular Advisory Committee. Multiple reference codes (e.g., 1721676, 3032916632) correspond to its regulatory registration and product classification.
Other devices from ICU Medical, Inc.
Questions
AI-generated answers, 20 Sep 2026
What clinical measurements does the Piccox catheter enable, and how does it differ from standard central venous catheters?
The Piccox catheter provides continuous in vivo measurement of central venous oxygen saturation (ScvO₂) using fiber-optic technology, which is not available in standard central venous catheters. Additionally, it allows for intravenous therapy, blood sampling, and pressure injection of contrast media—making it versatile for monitoring oxygenation while performing diagnostic procedures like angiography.
Is the Piccox catheter reusable, or is it intended for single-use only?
The Piccox catheter is explicitly designed for single-use in clinical settings. It is supplied sterile, which aligns with single-use medical device standards to ensure patient safety and prevent cross-contamination.
How is the Piccox catheter regulated in the U.S., and what committee reviewed its submission?
The Piccox catheter received a Traditional 510(k) clearance from the FDA, classified under Class II (870.1230). Its submission was reviewed by the Cardiovascular Advisory Committee (CV), which evaluates cardiovascular-related devices for safety and effectiveness before clearance.
What types of medical specialties commonly use this device, and why?
The Piccox catheter is categorized under Cardiovascular medical specialties, meaning it is primarily used in critical care, intensive care units (ICUs), and cardiovascular procedures. Its ability to monitor ScvO₂ continuously while enabling contrast injections makes it valuable for assessing hemodynamic stability and guiding interventions in patients with complex cardiovascular conditions.
How should the Piccox catheter be stored before use, and what precautions should be taken?
Since the Piccox catheter is sterile and single-use, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until immediate use to maintain sterility and prevent contamination.