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510(k) K971022

CHASE SUCKER by Chase Medical, Inc. — Product Code GCX

K971022 is an FDA 510(k) premarket notification submitted by Chase Medical, Inc. for the device "CHASE SUCKER". The FDA issued a decision of Substantially Equivalent on April 17, 1997. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Chase Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 1997
Date Received
March 20, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
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 GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)
  • K954869 — MEDCARE YANKAUER SUCTION DEVICE (January 19, 1996)

FDA data resources