3T Blood Collection Cardiotomy Reservoirs and Accessories

FDA 510(k) K072697 · 3t Medical Systems, LLC

Substantially Equivalent

510(k) numberK072697

Submission

Device name
3T Blood Collection Cardiotomy Reservoirs and Accessories
Applicant
3t Medical Systems, LLC
Conifer, CO, US
Received
September 24, 2007
Decision date
December 20, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DTN – Reservoir, Blood, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4400
Specialty
Cardiovascular

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Questions and answers

When was 3T Blood Collection Cardiotomy Reservoirs and Accessories cleared by the FDA?

3T Blood Collection Cardiotomy Reservoirs and Accessories (K072697) received a 510(k) decision of Substantially Equivalent on December 20, 2007, 87 days after the submission was received.

What is the product code of K072697?

The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.