ClearanceBrief
Panels › Cardiovascular › Product code DSP · Class 2

System, Balloon, Intra-Aortic And Control

Regulation 870.3535

0510(k)s in 12 months (162 all time)
7recalls in 12 months (194 all time)
181recalls that name a 510(k)
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Top companies in DSP

Company510(k)sRecalls
Datascope Corp.64101
Arrow International, Inc.763
Kontron Instruments, Inc.170
Arrow Intl., Inc.150
Arrow International, Inc., Division of Teleflex Medical Inc.014
Boston Scientific Corp140
Maquet Datascope Corp - Cardiac Assist Division014
Aries Medical, Inc.80
Smec, Inc.70
Belmont Instrument Corp.50
Decided510(k)Device and applicantCode
Aug 3, 1981K811372MODEL 84 TRANSPORT SYSTEM
Datascope Corp.
DSP
May 6, 1981K810297DATASCOPE PERCOR=DL DUAL-LUMEN INTRA
Datascope Corp.
DSP
Mar 11, 1981K802924KONTRON PERCUTAEOUS DOUBLE-LUMEN
Avco Medical Products
DSP
Jan 13, 1981K802167PERCOR DATASCOPE INTRA-AORTIC BALLOON
Datascope Corp.
DSP
Jan 13, 1981K801601DATASCOPE/AVCO CONNECTOR
Datascope Corp.
DSP
May 14, 1980K790755SMEC BALLOON CANNULA
Smec, Inc.
DSP
Oct 1, 1979K790775INTRA-AORTIC BALLOON, TYPE S
Datascope Corp.
DSP
Feb 23, 1979K790241INTRA-AORTIC BALLOON-PUMP
Avco Medical Products
DSP
Jan 23, 1979K781848PUMP, BALLOON MODEL 10
Avco Medical Products
DSP
Mar 15, 1978K780280BALLOON PUMP
Datascope Corp.
DSP
May 6, 1977K770821PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT
Avco Medical Products
DSP
Oct 6, 1976K760695TAMARI-KAPLITT
Yehuda Tamari
DSP

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