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510(k) K875324

MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES by Schneider-Shilley (Usa) — Product Code DXT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1988
Date Received
December 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type

Other clearances by Schneider-Shilley (Usa)

  • K882826 — SOFTRAC-PTA PERIPHERAL DILATATION CATHETER (January 24, 1989)
  • K875175 — MODIFIED PERIPHERAL DILATATION CATHETERS (July 28, 1988)
  • K881197 — SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER (May 16, 1988)
  • K875322 — MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER (March 28, 1988)
  • K875323 — MODIFIED SCHNEIDER-SHILEY WIRE TORQUER (March 28, 1988)
  • K875327 — MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT (March 25, 1988)
  • K875325 — MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK (February 18, 1988)
  • K875326 — MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER (February 18, 1988)

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