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510(k) K875175

MODIFIED PERIPHERAL DILATATION CATHETERS by Schneider-Shilley (Usa) — Product Code LIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1988
Date Received
December 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Schneider-Shilley (Usa)

  • K882826 — SOFTRAC-PTA PERIPHERAL DILATATION CATHETER (January 24, 1989)
  • K881197 — SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER (May 16, 1988)
  • K875323 — MODIFIED SCHNEIDER-SHILEY WIRE TORQUER (March 28, 1988)
  • K875322 — MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER (March 28, 1988)
  • K875327 — MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT (March 25, 1988)
  • K875324 — MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES (March 25, 1988)
  • K875326 — MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER (February 18, 1988)
  • K875325 — MODIFIED OCCLUDER/FLUSHING CATHETER STOPCOCK (February 18, 1988)

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