Compact Monitor SMK 210,211,230,231,240

FDA 510(k) K903917 · Ppg Hellige B.V.

Substantially Equivalent

510(k) numberK903917

Submission

Device name
Compact Monitor SMK 210,211,230,231,240
Applicant
Ppg Hellige B.V.
West Germany, DE
Received
August 24, 1990
Decision date
January 18, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DSP – System, Balloon, Intra-Aortic And Control
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3535
Specialty
Cardiovascular

Other 510(k)s with product code DSP

510(k)DeviceApplicantDecision
K250542AC3™ Range™ Intra-Aortic Balloon PumpDSP · Special Arrow International, LLC03/26/2025SE
K232343AC3™ Series IABPDSP · Special Arrow International, LLC08/30/2023SE
K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPDSP · Special Arrow International, Inc.05/27/2020SE
K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitDSP · Special Arrow International, Inc.04/09/2020SE
K192238AC3 Series Intra-Aortic Balloon Pump (IABP)DSP · Special Arrow International, Teleflex11/12/2019SE
K190101UltraFlex IABDSP · Traditional Arrow International, Inc.06/28/2019SE
K190117Fiberoptix IABDSP · Traditional Arrow International, Inc.06/13/2019SE
K181122CARDIOSAVE Intra-Aortic Balloon PumpDSP · Special Datascope Corp.05/31/2018SE
K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDSP · Special Datascope Corp.10/12/2017SE
K162820AC3 Series IABP SystemDSP · Traditional Arrow International, Inc.03/31/2017SE

More from Arrow International, Inc.

510(k)DeviceDecision
K921666Cardiac Theraphy System SCP 900LDD · Traditional 09/23/1993SE
K903900Smu 611 Vers. 2.0 Including Pressni,Dilu,Sat-Mod.DSK · Traditional 01/08/1991SE

Questions and answers

When was Compact Monitor SMK 210,211,230,231,240 cleared by the FDA?

Compact Monitor SMK 210,211,230,231,240 (K903917) received a 510(k) decision of Substantially Equivalent on January 18, 1991, 147 days after the submission was received.

What is the product code of K903917?

The FDA product code is DSP – System, Balloon, Intra-Aortic And Control, a Class II (moderate risk) device regulated under 21 CFR 870.3535.