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510(k) K040447

TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 by Boston Scientific Corp — Product Code LQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2004
Date Received
February 20, 2004
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Biliary Mechanical
Device Class
Class II
Regulation Number
876.4500
Review Panel
GU
Submission Type

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Other clearances for product code LQC

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  • K964937 — A LITHOTRIPTER-COMPATIBLE BASKET (January 24, 1997)
  • K942544 — GIP/MEDI-GLOBE MECHANICAL LITHOTRIPTOR AND BASKETS (November 22, 1994)
  • K943191 — MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR (August 29, 1994)
  • K905552 — LAPAROLITH (December 17, 1991)
  • K911364 — SPOON FORCEPS, 11MM (October 23, 1991)
  • K911477 — LAPAROSCOPIC BASKET FLEXIBLE AND RIGID (August 14, 1991)
  • K903529 — BML SERIES (January 23, 1991)
  • K902170 — SOEHENDRA LITHOTRIPSY SET (July 25, 1990)
  • K860863 — ENDO-TRIPTON, MECHANICAL GALLSTONE CRUSHER (May 15, 1986)