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Panels › Cardiovascular › Product code DQR · Class 2

Cannula, Catheter

Regulation 870.1300

0510(k)s in 12 months (25 all time)
0recalls in 12 months (26 all time)
26recalls that name a 510(k)
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Top companies in DQR

DateFirm and productCodeLinked 510(k)
Jul 10, 2025Edwards Lifesciences, LLC
Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or
Open, Classified
DQRK140208
Jul 10, 2025Edwards Lifesciences, LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or e
Open, Classified
DQRK140208
Jul 10, 2025Edwards Lifesciences, LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or
Open, Classified
DQRK140208
Jul 10, 2025Edwards Lifesciences, LLC
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or e
Open, Classified
DQRK140208
Jul 10, 2025Edwards Lifesciences, LLC
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Per
Open, Classified
DQRK073559
Jul 10, 2025Edwards Lifesciences, LLC
Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Per
Open, Classified
DQRK073559
Oct 14, 2020Angiodynamics, Inc.
Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355
Terminated
DQRK051655
Mar 7, 2018SPS Sterilization, Inc
Edwards Lifesciences Optisite Arterial Perfusion Cannula, 22F X 24CM, resterilized.
Terminated
DQRK073559
May 25, 2013Angiodynamics, Inc.
AngioDynamics Micro Introducer Kits under the following labeling: 1) AngioDynamics 4F Standard Micro-Introducer Kit, Sterile, Catalog Number: 06597005, 2) AngioDynamics 5F Standard Micro-Introducer K
Terminated
DQRK051655
Jul 20, 2004Guidant Corp-Cpi Division
Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Straight Right Tip Shape, CS-EH ST R, REF 7593
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Lenght 54 cm, Coronary Sinus - Extended Hook Right Tip Shape, CS-EH R, REF 7592
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 7576
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Lenght 54 cm, Coronary Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 7576
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Multi-Purpose Long Tip Shape, CS-MPL, REF 7507
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Hook Tip Shape, CS-H, REF 7438
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Multi-Purpose Hook Tip Shape, CS-MPH, REF 7369
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Multi-Purpose Tip Shape, CS-MP, REF 7300
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant Rapido 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, Coronary Sinus - Extended Hook Tip Shape, CS-Extended H, REF 6778
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 49 cm, Coronary Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 6758
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 49 cm, Coronary Sinus - Multi-Purpose Long Tip Shape, CS-MPL, REF 6756
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 49 cm, Coronary Sinus - Hook Tip Shape, CS-H, REF 6754
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 49 cm, Coronary Sinus - Multi-Purpose Hook Tip Shape, CS-MPH, REF 6752
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 49 cm, Coronary Sinus - Multi-Purpose Tip Shape, CS-MP, REF 6717
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 44 cm, Coronary Sinus - Multi-Purpose Tip Shape, CS-MP, REF 6716
Terminated
DQRK021284
K021455
Jul 20, 2004Guidant Corp-Cpi Division
Guidant EasyTrak 8 French Guiding Catheter, Inner Diameter .087'', 2.21 mm, Overall Length 54 cm, CS Wide Tip Shape, CS-W, REF 6705
Terminated
DQRK021284
K021455

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