TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T

Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

MEDTRONIC PERFUSION SYSTEMS

The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Trillium Tri-optic Measurement Cell, Model Tmc 25t, Tmc38 T, Tmc 50t.

Pre-market Notification Details

• Device ID: K012743
• 510k Number: K012743
• Device Name: TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T
• Classification: Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
• Applicant: MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038
• Contact: Marie Holm
• Correspondent: Marie Holm; MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038
• Product Code: DRY
• CFR Regulation Number: 870.4330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-08-16
• Decision Date: 2001-09-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20681490009830	K012743	000
20681490009823	K012743	000
20681490009816	K012743	000
20721902358948	K012743	000
20721902358917	K012743	000