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510(k) K190475

Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 by Centerpoint Systems — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2019
Date Received
February 27, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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