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510(k) K011040

CRYOCARE CARDIAC SURGICAL SYSTEM by Endocare, Inc. — Product Code OCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2001
Date Received
April 5, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue
Device Class
Class II
Regulation Number
878.4400
Review Panel
CV
Submission Type

Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

Other clearances by Endocare, Inc.

  • K101333 — CRYOCARE CS SURGICAL SYSTEM (June 14, 2010)
  • K062175 — CRYOCARE CN2 SYSTEM (August 28, 2006)
  • K060279 — CRYOCARE CS SURGICAL SYSTEM (February 28, 2006)
  • K050347 — MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM (February 25, 2005)
  • K032333 — CRYOCARE CS SURGICAL SYSTEM (August 12, 2003)
  • K023757 — CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 (December 5, 2002)
  • K021010 — MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE (June 6, 2002)
  • K020082 — ERECAID CLASSIC SYSTEM; ERECAID ESTEEM MANUAL SYSTEM; ERECAID ESTEEM BATTERY SYS (February 5, 2002)
  • K011074 — CRYOCARE SURGICAL SYSTEM (January 25, 2002)
  • K003811 — CRYOCARE SURGICAL SYSTEM (October 11, 2001)

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