FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

FRESENIUS MEDICAL CARE NORTH AMERICA

The following data is part of a premarket notification filed by Fresenius Medical Care North America with the FDA for Fresenius Combilines Low Volume Blood Tubing Set, Models 03-2291 (post Pump) And 03-2292 (pre-pump).

Pre-market Notification Details

• Device ID: K001107
• 510k Number: K001107
• Device Name: FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
• Classification: Set, Tubing, Blood, With And Without Anti-regurgitation Valve
• Applicant: FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02173
• Contact: Arthur Eilinsfeld
• Correspondent: Arthur Eilinsfeld; FRESENIUS MEDICAL CARE NORTH AMERICA 95 HAYDEN AVE. Lexington, MA 02173
• Product Code: FJK
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-04-05
• Decision Date: 2000-06-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10840861100269	K001107	000