Schurman/Carter II Hip Prosthesis, Porous Coated

FDA 510(k) K874939 · Kirschner Medical Corp.

Substantially Equivalent for Some Indications

510(k) numberK874939

Submission

Device name
Schurman/Carter II Hip Prosthesis, Porous Coated
Applicant
Kirschner Medical Corp.
Timonium, MD, US
Received
December 2, 1987
Decision date
February 2, 1988
Decision
Substantially Equivalent for Some Indications (SN)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DXQ – Blood Pressure Cuff
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1120
Specialty
Cardiovascular

A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

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More from Suzhou Minhua Medical Apparatus Supplies Co., Ltd.

510(k)DeviceDecision
K940537Kirschner(R) Modular Ii-C(Tm) Total Shoulder SystemKWT · Traditional 08/29/1995SE
K936274Kirschner Performance Posterior Stabilized Total Knee SystemJWH · Traditional 01/18/1995SE
K942891Summit Total Hip SystemMEH · Traditional 11/02/1994SE
K941486Integrity Total Hip System, Non-PorousJDI · Traditional 09/20/1994SE
K933843Line Extension for Kirschner Performance Total Knee System, Porous CoatedJWH · Traditional 08/05/1994SE
K935951Kirschner C-2 Osteocap Total Hip SystemJDI · Traditional 07/18/1994SE
K935206Kirschner Integrity Acetabular Cup ModificationJDI · Traditional 07/13/1994SE
K934589Kirschner Performance Total Knee System Porous CoatedJWH · Traditional 07/13/1994SN
K934694Kirschner Zirconia Femoral HeadLZO · Traditional 05/18/1994SE
K920188Threaded PinsMBJ · Traditional 05/12/1993SE

Questions and answers

When was Schurman/Carter II Hip Prosthesis, Porous Coated cleared by the FDA?

Schurman/Carter II Hip Prosthesis, Porous Coated (K874939) received a 510(k) decision of Substantially Equivalent for Some Indications on February 2, 1988, 62 days after the submission was received.

What is the product code of K874939?

The FDA product code is DXQ – Blood Pressure Cuff, a Class II (moderate risk) device regulated under 21 CFR 870.1120.