PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER

Catheter, Oximeter, Fiber-optic

ICU MEDICAL, INC.

The following data is part of a premarket notification filed by Icu Medical, Inc. with the FDA for Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry Catheter.

Pre-market Notification Details

• Device ID: K140129
• 510k Number: K140129
• Device Name: PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
• Classification: Catheter, Oximeter, Fiber-optic
• Applicant: ICU MEDICAL, INC. 4455 ATHERTON DRIVE Salt Lake City, UT 84123
• Contact: Kristin Casper
• Correspondent: Kristin Casper; ICU MEDICAL, INC. 4455 ATHERTON DRIVE Salt Lake City, UT 84123
• Product Code: DQE
• CFR Regulation Number: 870.1230 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-01-16
• Decision Date: 2014-07-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10887709061702	K140129	000