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510(k) K152090

Reprocessed Steerable Introducer by Sterilmed, Inc. — Product Code PNE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2016
Date Received
July 27, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reprocessed Catheter Introducer
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Introduce various cardiovascular catheters into the heart and cardiovascular system

Other clearances by Sterilmed, Inc.

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  • K161700 — SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D D (November 21, 2016)
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  • K153006 — Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) (June 23, 2016)
  • K152134 — Reprocessed Vessel Sealer (January 15, 2016)
  • K150357 — Reprocessed Electrophysiology Diagnostic Catheters (August 27, 2015)
  • K143562 — Reprocessed Cordless Ultrasonic Dissection Device (May 20, 2015)

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  • K230376 — Reprocessed Agilis NxT Steerable Introducer (August 7, 2023)
  • K212165 — Reprocessed Carto Vizigo Bi-Directional Guiding Sheath (March 10, 2022)
  • K170311 — Reprocessed Agilis NxT Steerable Introducer (June 2, 2017)