Evans Medical Extension Sets

FDA 510(k) K935642 · Evans Medical, Inc.

Substantially Equivalent

510(k) numberK935642

Submission

Device name
Evans Medical Extension Sets
Applicant
Evans Medical, Inc.
Pineville, PA, US
Received
November 22, 1993
Decision date
January 28, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FPK – Tubing, Fluid Delivery
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5440
Specialty
General Hospital

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K022431Medrad Transfer SetFPK · Traditional Medrad, Inc.09/05/2002SE
K965208Polyfin Extension Set, Models 126 and 128FPK · Traditional Medtronic Minimed02/26/1997SE
K953864Silclear Tubing (Modification)FPK · Traditional Degania Silicone , Ltd.11/06/1995SE
K950508Sysmex SF-3000FPK · Traditional Sysmex Corp.11/03/1995SE

More from Sysmex Corp.

510(k)DeviceDecision
K020530Evans Sub-Q, Model MC4206FPA · Traditional 04/29/2002SE
K9356410.2. Micron Filter Sets and 1.2 Micron Filter SetsFPB · Traditional 01/28/1994SE
K935480Medical Specialties Non-Coring Needle Admin SetsFMI · Traditional 01/28/1994SE

Questions and answers

When was Evans Medical Extension Sets cleared by the FDA?

Evans Medical Extension Sets (K935642) received a 510(k) decision of Substantially Equivalent on January 28, 1994, 67 days after the submission was received.

What is the product code of K935642?

The FDA product code is FPK – Tubing, Fluid Delivery, a Class II (moderate risk) device regulated under 21 CFR 880.5440.