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510(k) K875327

MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT by Schneider-Shilley (Usa) — Product Code DRE

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
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
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)
  • K875324 — MODIFIED SCHNEIDER SHILEY INFLATION SYRINGES (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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