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510(k) K911451

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

K911451 is an FDA 510(k) premarket notification submitted by Filtertek, Inc. for the device "I.V. EXTENDER SET". The FDA issued a decision of Substantially Equivalent on June 6, 1991. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Filtertek, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1991
Date Received
April 3, 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)
  • K912848 — I.V. FILTER EXTENSION SET (November 29, 1991)
  • K912394 — TRANSDUCER PROTECTOR (August 30, 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)

Other clearances for product code FPB

  • K261403 — Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor (August 31, 2026)
  • K233277 — Filter Needle for Single Use (May 10, 2024)
  • K143583 — Cathivex ¿GV filter units (August 11, 2015)
  • K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (December 8, 2011)
  • K021293 — ARTERIA BLOOD FILTER (August 22, 2002)
  • K993379 — PALL SUPOR AEF FILTER (December 16, 1999)
  • K974661 — 0.2 U BACTERIAL FILTER (February 11, 1998)
  • K964283 — AUTOPRIME (January 22, 1997)
  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K933523 — I.V. FILTER SET (May 19, 1995)

FDA data resources