ClearanceBrief
Product code DSQ ยท Class 3

Ventricular (Assist) Bypass

0510(k)s in 12 months (0 all time)
8recalls in 12 months (131 all time)
1recalls that name a 510(k)
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Top companies in DSQ

Company510(k)sRecalls
HeartWare Inc075
Thoratec Corp042
Abiomed, Inc.05
Medtronic Inc03
BERLIN HEART GMBH02
Abbott01
Datascope Corporation01
Jarvik Heart Inc01
Thoratec Switzerland GMBH01
DateFirm and productCodeLinked 510(k)
Jun 18, 2026Thoratec LLC
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Description: The HeartMate 11 Volt Lithium Ion Standalone Backup Batter
Open, Classified
DSQNone listed
Jun 18, 2026Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central powe
Open, Classified
DSQNone listed
Jun 18, 2026Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist S
Open, Classified
DSQNone listed
Jun 5, 2026BERLIN HEART GMBH
EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml, REF: P10P-001; 30 ml, REF: P30P-001x01
Open, Classified
DSQNone listed
Nov 14, 2025Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate II Controller (standalone) Model/Catalog Number: 106017, HeartMate II Pocket Controller, US; 106762, HeartMate II Pocket Controller, US; 107801, HeartMate
Open, Classified
DSQNone listed
Nov 14, 2025Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate II LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II LVAS Kit, with Pocket Co
Open, Classified
DSQNone listed
Nov 14, 2025Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low F
Open, Classified
DSQNone listed
Nov 14, 2025Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Vers
Open, Classified
DSQNone listed
Aug 13, 2025Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipme
Open, Classified
DSQNone listed
Aug 13, 2025Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a
Open, Classified
DSQNone listed
Apr 17, 2025Thoratec LLC
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
Open, Classified
DSQNone listed
Aug 13, 2024Thoratec LLC
HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524
Open, Classified
DSQNone listed
Jun 27, 2024Thoratec Switzerland GMBH
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System
Open, Classified
DSQNone listed
Jun 7, 2024Thoratec Corp.
Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L1286C, L1386, 1286A-CAN, 1286INT and L1286INT. Left ventricular assist device
Open, Classified
DSQNone listed
May 1, 2024Thoratec Corp.
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly
Open, Classified
DSQNone listed
May 1, 2024Thoratec Corp.
Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
Open, Classified
DSQNone listed
Mar 22, 2024Thoratec Corp.
HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Relief, Investigational Device Exemption (IDE) 2. HeartMate 3 Sealed Outflow Graft with Bend Relief,
Open, Classified
DSQNone listed
Mar 22, 2024Thoratec Corp.
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit
Open, Classified
DSQNone listed
Feb 2, 2024Thoratec Corp.
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is
Open, Classified
DSQNone listed
Dec 2, 2023Heartware, Inc.
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
Open, Classified
DSQNone listed
Dec 2, 2023Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Open, Classified
DSQNone listed
Dec 2, 2023Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Open, Classified
DSQNone listed
Dec 2, 2023Heartware, Inc.
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Open, Classified
DSQNone listed
Dec 2, 2023Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Open, Classified
DSQNone listed
Dec 2, 2023Heartware, Inc.
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Open, Classified
DSQNone listed
Dec 2, 2023Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
Open, Classified
DSQNone listed
Dec 2, 2023Heartware, Inc.
STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
Open, Classified
DSQNone listed
Dec 2, 2023Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Open, Classified
DSQNone listed
Sep 29, 2023Thoratec Corp.
Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
Open, Classified
DSQNone listed
Jun 22, 2023Heartware, Inc.
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
Open, Classified
DSQNone listed
May 25, 2023BERLIN HEART GMBH
EXCOR Pediatric Ventricular Assist Device Blood Pumps, Models: P10P-001 (10 ml blood pump); P15P-001 (10 ml blood pump); P25P-001x01 (25 ml blood pump); P30P-001x01 (30 ml blood pump), P50P-001 (50
Terminated
DSQNone listed
Dec 21, 2022Heartware, Inc.
HeartWare HVAD Pump Kit, REF MCS1705PU
Open, Classified
DSQNone listed
Dec 21, 2022Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1205
Open, Classified
DSQNone listed
Dec 21, 2022Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104JP
Open, Classified
DSQNone listed
Dec 21, 2022Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Open, Classified
DSQNone listed
Dec 21, 2022Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104
Open, Classified
DSQNone listed
Dec 21, 2022Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1103
Open, Classified
DSQNone listed
Dec 21, 2022Heartware, Inc.
HeartWare Model 1102
Open, Classified
DSQNone listed
Dec 21, 2022Heartware, Inc.
HeartWare Model 1101
Open, Classified
DSQNone listed
Dec 21, 2022Heartware, Inc.
HeartWare Model 1100
Open, Classified
DSQNone listed
Oct 24, 2022Datascope Corporation
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Open, Classified
DSQK041281
Aug 18, 2022Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Open, Classified
DSQNone listed
May 5, 2022Medtronic Inc
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Open, Classified
DSQNone listed
Apr 14, 2022Medtronic Inc
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Open, Classified
DSQNone listed
Mar 30, 2022Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Responder Guide (FI-Finnish) HVAD System Emergency Re
Open, Classified
DSQNone listed
Mar 30, 2022Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Open, Classified
DSQNone listed
Mar 30, 2022Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Open, Classified
DSQNone listed
Mar 30, 2022Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Open, Classified
DSQNone listed
Mar 30, 2022Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Open, Classified
DSQNone listed
Mar 30, 2022Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Open, Classified
DSQNone listed

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