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510(k) K971021

CHASE PHRENIC NERVE PAD by Chase Medical, Inc. — Product Code DWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1997
Date Received
March 20, 1997
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 Chase Medical, Inc.

  • K072473 — CHASE MR SYSTEM (December 10, 2007)
  • K062031 — CHASE CARDIAC ANALYSIS SYSTEM (September 27, 2006)
  • K032531 — CHASE CARDIAC ANALYSIS SYSTEM (February 2, 2004)
  • K022093 — CHASE CARDIOVASCULAR PATCH KIT (September 20, 2002)
  • K021129 — CHARE CARIOVASCULAR PATCH (June 3, 2002)
  • K020233 — CHASE CARDIOVASCULAR PATCH KIT (March 14, 2002)
  • K020132 — CHASE CARDIOVASCULAR PATCH KIT (February 26, 2002)
  • K012248 — CHASE CARDIOVASCULAR PATCH (August 10, 2001)
  • K003467 — CHASE CARDIOVASCULAR PATCH (January 29, 2001)
  • K001662 — CHASE CARDIOVASCULAR PATCH (August 2, 2000)

Other clearances for product code DWF

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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)