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510(k) K912848

I.V. FILTER EXTENSION SET by Filtertek, Inc. — Product Code FPB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1991
Date Received
June 28, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Filtertek, Inc.

  • K981547 — NFC NEEDLEFREE Y-SITE, MODEL 69970 (June 18, 1998)
  • K981548 — NFC NEEDLEFREE CONNECTOR MODEL 69900 (June 18, 1998)
  • K914792 — PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET (January 15, 1992)
  • K912394 — TRANSDUCER PROTECTOR (August 30, 1991)
  • K911451 — I.V. EXTENDER SET (June 6, 1991)
  • K904912 — TRANSDUCER PROTECTOR (January 4, 1991)
  • K901409 — TRANSDUCER PROTECTOR (July 27, 1990)
  • K901996 — FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR (June 1, 1990)
  • K895281 — TRANSDUCER PROTECTOR (November 8, 1989)

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  • K933523 — I.V. FILTER SET (May 19, 1995)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)