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510(k) K845037

PERCUTANEOUS ANGIOGRAPHIC NEEDLES by Mallinckrodt Critical Care — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1985
Date Received
December 27, 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 Mallinckrodt Critical Care

  • K880343 — BURNEY GALLBLADDER CATHETER KIT (May 1, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)
  • K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE (January 29, 1988)
  • K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR (January 6, 1988)
  • K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) (November 6, 1987)
  • K874404 — HI-LO TEMP(R) SKIN TEMPERATURE SENSOR (November 6, 1987)
  • K873833 — THERMOCOUPLE ADAPTER (November 3, 1987)
  • K873004 — GUIDING CATHETER (September 15, 1987)
  • K871204 — CUFFED TRACHEAL TUBE (MULTIPLE) (April 21, 1987)
  • K862666 — UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) (August 1, 1986)

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