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510(k) K902469

BYRD DILATOR SHEATH SET - TEFLON by Medical Engineering and Development Institute — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1990
Date Received
June 4, 1990
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 Medical Engineering and Development Institute

  • K902477 — WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET (August 24, 1990)
  • K902502 — BYRD STAINLESS STEEL DILATOR (August 7, 1990)
  • K895030 — LIFE-LINE(TM) VASCULAR ACCESS SYSTEM (April 17, 1990)
  • K893480 — BYRD EXTRACTOR SET (June 23, 1989)
  • K890820 — LOCKING WIRE GUIDE STYLET (March 22, 1989)

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