FDA 510(k)

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters

Número K: K162625 · 2017-06-12

RequerenteB. Braun Interventional Systems, Inc.

Data da decisão2017-06-12

Código do produtoLOX

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is the device name listed in this FDA 510(k) record. The listed applicant is B. Braun Interventional Systems, Inc.. It received FDA 510(k) clearance on 2017-06-12 under 510(k) number K162625. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is a medical device that received FDA 510(k) clearance on 2017-06-12. The listed applicant is B. Braun Interventional Systems, Inc.. The 510(k) number is K162625.

When did SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters receive FDA 510(k) clearance?

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters received FDA 510(k) clearance on 2017-06-12, under 510(k) number K162625.

Who is the listed applicant for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

The FDA 510(k) record lists B. Braun Interventional Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters?

The FDA product code for SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters is LOX.

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