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510(k) K181056

Reprocessed CS Diagnostic Electrophysiology Catheter by Stryker Sustainability Solutions — Product Code NLH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2019
Date Received
April 20, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Recording, Electrode, Reprocessed
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

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