FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

MPC-740: The MPC-740 is a Male to Male Dialysate Connection Connector. It may be used to connect the MPC-725 to the Dialysis machine Dialysate Line in order to extend the length of the Dialysate Tubing. May also be used as a recirculation connector; connecting both dialysis machine Dialysate lines together.
MPC-725: The MPC-725 is a Female to Female Dialysate Connection Connector. When connected to the MPC-740 (which has been connected to the dialysis machines' dialysate line) this line may be used to extend the length of the Dialysis Machine Dialysate Line. The MPC-725 may also be used to connect one Dialyzer Port to another Dialyzer Port.

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AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding "Dialysate Tubing with Connectors MPC-725 and MPC-740". This document is an approval letter for a medical device and does not contain information related to acceptance criteria, device performance, or a study proving its conformance.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on clinical or performance study results.

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K Number

K010712

Device Name

DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES

Manufacturer

MOLDED PRODUCTS INC.

Date Cleared

2001-09-27

(202 days)

Product Code