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510(k) K100254

REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER by Ascent Healthcare Solutions — Product Code NLH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2010
Date Received
January 28, 2010
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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  • K082023 — REPROCESSED ELECTROPHYSIOLOGY CATHETERS (September 16, 2008)
  • K081238 — REPROCESSED MASIMO PULSE OXIMETER SENSORS (July 29, 2008)

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