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510(k) K080154

ACUITY UNIVERSAL CUTTER by Cardiac Pacemakers, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2008
Date Received
January 23, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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  • K905674 — LEAD STYLET (January 30, 1991)
  • K900498 — MODIFIED BETATRON IV INSULIN INFUSION SYSTEM (February 23, 1990)
  • K894738 — MODEL 6888 LEAD TUNNELER (September 13, 1989)
  • K890785 — ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE (March 10, 1989)
  • K875147 — TORQUE HEX WRENCH (January 27, 1988)
  • K872774 — BETATRON IV SYSTEM (January 5, 1988)

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