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510(k) K844593

CARDIOVASCULAR CUSTOM SURGICAL KIT by Xanmed Corp. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1985
Date Received
November 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Xanmed Corp.

  • K864623 — OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT (January 14, 1987)
  • K844595 — ORTHOPEDIC CUSTOM SURGICAL KIT (August 21, 1985)
  • K844596 — EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT (August 1, 1985)
  • K844594 — NEURO CUSTOM SURGICAL KIT (June 13, 1985)
  • K851906 — SURGICAL EYE PACK (May 21, 1985)
  • K844597 — MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT (April 8, 1985)
  • K843641 — CATHETER INTRODUCER SYSTEM (October 23, 1984)
  • K843642 — SUBCLAVIAN LEAD INTRODUCER SYS (October 23, 1984)

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