Tubing, Dialysate (and Connector)

FDA 510(k) K022068 · Molded Products, Inc.

Substantially Equivalent

510(k) numberK022068

Submission

Device name
Tubing, Dialysate (and Connector)
Applicant
Molded Products, Inc.
Harlan, IA, US
Received
June 25, 2002
Decision date
September 23, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FID – Tubing, Dialysate
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

Other 510(k)s with product code FID

510(k)DeviceApplicantDecision
K010712Dialysate Line with Connectors/Re-Use Wash-Out LinesFID · Abbreviated Molded Products, Inc.09/27/2001SE
K770299Tygon M-60/TYGON M-70FID · Traditional Norton Performance Plastics Corp.03/16/1977SE

More from Norton Performance Plastics Corp.

510(k)DeviceDecision
K010366Disposable Storage CapFJI · Abbreviated 11/28/2001SE
K010712Dialysate Line with Connectors/Re-Use Wash-Out LinesFID · Abbreviated 09/27/2001SE
K003712Modification to Male to Male Luer AdapterKOC · Traditional 05/16/2001SE
K925978MPC-80 TransducerFIB · Traditional 01/14/1994SE
K925930MPC-150 Male to Male Luer AdapterFPA · Traditional 08/16/1993SE
K925927MPC-1000 Injection Cap/PlugFPA · Traditional 08/16/1993SE

Questions and answers

When was Tubing, Dialysate (and Connector) cleared by the FDA?

Tubing, Dialysate (and Connector) (K022068) received a 510(k) decision of Substantially Equivalent on September 23, 2002, 90 days after the submission was received.

What is the product code of K022068?

The FDA product code is FID – Tubing, Dialysate, a Class II (moderate risk) device regulated under 21 CFR 876.5820.