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510(k) K011336

PRIMARY SOLUTION SET WITH UNIVERSAL SPIKE, INJECTION SITE AND MALE LUER LOCK by Churchill Medical Systems, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2001
Date Received
May 2, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Churchill Medical Systems, Inc.

  • K041038 — CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER (December 21, 2004)
  • K021395 — MODIFICATION TO 30 EXTENSION SET (May 13, 2002)
  • K013949 — UNIVERSAL VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR (March 27, 2002)
  • K020544 — WING SAFE INFUSION SET 20 GA, SHS2000 SERIES; WING SAFE INFUSION SET 19 GA, SHS1 (March 12, 2002)
  • K013950 — VENTED VIAL ACCESS DEVICE (January 10, 2002)
  • K012157 — CHURCHILL MEDICAL SYSTEMS STOPCOCK (September 11, 2001)
  • K011888 — PRESSURE ACTIVATED CHECK VALVE (September 10, 2001)
  • K896333 — CMS IV FILTERS (January 11, 1990)
  • K894954 — .22 & 1.2 MICRON IV FILTERS (November 13, 1989)
  • K884370 — CMS IV EXTENSION SETS (November 7, 1988)

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