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510(k) K200289

Michler-Kapp Cardiovascular Vent Catheter by Kapp Surgical Instrument, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2021
Date Received
February 5, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4210
Review Panel
CV
Submission Type

Other clearances by Kapp Surgical Instrument, Inc.

  • K072216 — KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 (November 9, 2007)
  • K050384 — KAPP BARI-RING, MODEL KS-BR-2005 (January 13, 2006)
  • K050657 — MONDEAL CONTOUR HO SYSTEM (August 8, 2005)
  • K050655 — MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005 (August 8, 2005)
  • K033930 — KAPP CUSTOM ULNAR HEAD WRIST IMPLANT (July 28, 2004)
  • K030237 — KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT (August 29, 2003)
  • K844177 — COSGROVE MITRAL VALVE RETRACTOR (November 8, 1984)
  • K843368 — KAPP SPINAL BUTTON (September 12, 1984)

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  • K253203 — Retrograde Coronary Sinus Perfusion Cannulae (February 19, 2026)
  • K253671 — Dual Stage Venous Cannulae (January 30, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K253106 — AngioVac Cannula (October 24, 2025)
  • K250283 — RAP Femoral Venous Cannulae (July 10, 2025)
  • K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (June 27, 2025)
  • K251258 — MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (June 20, 2025)
  • K241248 — Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) (May 31, 2024)