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510(k) K972957

SA-EF MULTI-LUMEN EXTENSION SET by Vlv Associates, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1997
Date Received
August 11, 1997
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 Vlv Associates, Inc.

  • K964876 — SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET (February 28, 1997)
  • K955783 — VLV SA.EF INFUSION PORT EXTENSION SETS (February 7, 1996)
  • K953791 — VLV SA EF INFUSION PORT (October 30, 1995)
  • K945592 — VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE (July 14, 1995)
  • K940406 — DISPOSABLE, AMBULATORY, INFUSION PUMPS (September 2, 1994)
  • K933364 — PROMED BIOPSY NEEDLE (February 15, 1994)
  • K922469 — PRO-LOK EXTENSION SET(S) (March 15, 1993)
  • K904217 — PRO-LOK (TM) EXTENSION SETS (October 3, 1990)
  • K901081 — PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY (June 8, 1990)
  • K901046 — VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR (June 8, 1990)

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