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510(k) K770589

FILTER, INTRAVENOUS W/AUTO AIR VENT by Jelco Laboratories — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1977
Date Received
March 28, 1977
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 Jelco Laboratories

  • K791918 — JELCO WINGED INTRAVASCULAR CATHETER (October 2, 1979)
  • K791372 — JELCO & KVO CATHETER PLACEMENT UNIT (September 12, 1979)
  • K790967 — CATHETER METAL HUB/RADIOPAQUE (June 27, 1979)
  • K790968 — CATHETER METAL HUB/NONRADIOPAQUE (June 11, 1979)
  • K790471 — JELCO* DISC FILTER-0.2 MICRON (April 30, 1979)
  • K790186 — PROTECTIVSTABILIZER (February 26, 1979)
  • K790107 — CATHETER TUBING MODIFICATION (February 1, 1979)
  • K790079 — NEEDLE, BLOOD COLLECTING (February 1, 1979)
  • K781857 — TRAY, ARTERIAL BLOOD GAS SAMPLING (December 11, 1978)
  • K780896 — NEEDLES, DESIGN CHANGE, IV CATHETERS (August 23, 1978)

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