HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS

Catheter, Oximeter, Fiber-optic

HOSPIRA, INC.

The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Hospira Latex-free Critical Care And Advanced Sensor Catheters.

Pre-market Notification Details

• Device ID: K091268
• 510k Number: K091268
• Device Name: HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
• Classification: Catheter, Oximeter, Fiber-optic
• Applicant: HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045
• Contact: Daniela Weksler
• Correspondent: Daniela Weksler; HOSPIRA, INC. 275 NORTH FIELD DR. Lake Forest, IL 60045
• Product Code: DQE
• Subsequent Product Code: DYG
• Subsequent Product Code: KRB
• CFR Regulation Number: 870.1230 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-04-30
• Decision Date: 2009-09-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10840619030091	K091268	000
10840619043770	K091268	000
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