Product code DQR— Cardiovascular

FDA has cleared 25 devices under product code DQR between 1977 and 2013, filed by 20 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20131 clearance
• 20081 clearance
• 20051 clearance
• 20031 clearance
• 19961 clearance
• 19911 clearance
• 19901 clearance
• 19895 clearances
• 19885 clearances
• 19873 clearances
• 19821 clearance
• 19811 clearance
• 19801 clearance
• 19781 clearance
• 19771 clearance

• Shiley, Inc.3 clearances
• Research Medical, Inc.2 clearances
• Medsurg Industries, Inc.2 clearances
• Harbor Medical Devices, Inc.2 clearances
• Toray Industries (America), Inc.1 clearance
• Sherwood Medical Industries1 clearance
• Medical Repackers Co.1 clearance
• Luther Medical Products, Inc.1 clearance
• Integra LifeSciences Corporation1 clearance
• Gresco International, Inc.1 clearance

Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• K131446 — INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLESIntegra LifeSciences Corporation·2013-10-28
• K073559 — 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA IIEdwards Lifesciences Research Medical·2008-01-31
• K051655 — ANGIODYNAMICS, INC., MICRO ACCESS KITSAngioDynamics, Inc.·2005-09-12
• K030398 — CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221Cardiacassist, Inc.·2003-05-23
• K960098 — RMI INTERNAL MAMMARY ARTERY CANNULAResearch Medical, Inc.·1996-03-26
• K902674 — DATASCOPE ARTERIAL CANNULA W/ACCESS PORTDatascope Corp.·1991-01-16
• K894784 — MODIFIED SHILEY FEMORAL VENOUS CANNULAShiley, Inc.·1990-03-28
• K894243 — RMI ARTERIAL PERFUSION CANNULAResearch Medical, Inc.·1989-09-19
• K884628 — HARBORIN CENTRAL VENOUS CATHETERHarbor Medical Devices, Inc.·1989-05-15
• K884478 — DAIG COLLAPSIBLE STERILE SLEEVEDaig Corp.·1989-02-22
• K884375 — TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETERArgon Medical Corp.·1989-01-11
• K882977 — ASK-300Medical Repackers Co.·1989-01-05
• K881884 — HARBOR CENTRAL VENOUS CATHETERHarbor Medical Devices, Inc.·1988-07-28
• K880771 — MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEMMedsurg Industries, Inc.·1988-05-03
• K873012 — INFANT CANNULAGresco International, Inc.·1988-05-02
• K880776 — 7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEMMedsurg Industries, Inc.·1988-05-02
• K874618 — BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETERBentley Laboratories, Inc.·1988-01-19
• K872983 — TORAY ANTHRON ANGIOGRAPHIC CATHETERSToray Industries (America), Inc.·1987-11-20
• K870825 — NEW MODEL STYLES FOR AORTIC ARCH CANNULAShiley, Inc.·1987-03-23
• K870826 — ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.Shiley, Inc.·1987-03-23
• K820102 — SUBCLAVIAN JUGULAR CATHETER SETLuther Medical Products, Inc.·1982-01-29
• K813144 — INTRAFLON, INTRAFLUX, INTRAVALVEExco, Inc.·1981-11-27
• K803002 — ELECATH FLUID-DRAIN ASSEMBLYElectro-Catheter Corp.·1980-12-22
• K780079 — CANNULA, ARTERY, RENALDravon Medical, Inc.·1978-02-13
• K770512 — CANNULA, INTRAVENOUS, RSherwood Medical Industries·1977-03-30