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510(k) K153006

Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) Catheter by Sterilmed, Inc. — Product Code NLH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2016
Date Received
October 14, 2015
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).

Other clearances by Sterilmed, Inc.

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  • K152134 — Reprocessed Vessel Sealer (January 15, 2016)
  • K150357 — Reprocessed Electrophysiology Diagnostic Catheters (August 27, 2015)
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  • K241224 — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer T (November 15, 2024)
  • K240826 — Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapo (October 11, 2024)
  • K241156 — Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter (September 14, 2024)
  • K240972 — Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) (June 7, 2024)
  • K233825 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (June 7, 2024)
  • K221067 — Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiolog (May 31, 2023)
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