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510(k) K162625

SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters by B. Braun Interventional Systems, Inc. — Product Code LOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2017
Date Received
September 20, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device Class
Class II
Regulation Number
870.5100
Review Panel
CV
Submission Type

A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end.

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