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510(k) K152310

HeartLight Deflectable Sheath by Cardiofocus, Inc. — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2016
Date Received
August 14, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

Other clearances by Cardiofocus, Inc.

  • K013201 — CARDIOFOCUS DIODE LASER SYSTEM, MODELS 60R, 60NR, 30NR (March 18, 2002)
  • K013901 — MALLEABLE SURGICAL LIGHTSTIC 180, MODEL 180 (1CM-9CM) (December 20, 2001)
  • K011988 — SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C (September 20, 2001)
  • K993834 — SURGICAL LIGHTSTIC, MODELS, 180 L, AND 180 C (February 4, 2000)

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  • K202620 — FlexCath Advance Steerable Sheath and Dilator (November 13, 2020)
  • K192422 — Steerable Introducer 12F (October 4, 2019)
  • K190167 — MitraClip G4 Steerable Guide Catheter (May 29, 2019)