Home / 510(k) Clearances / K893480

510(k) K893480

BYRD EXTRACTOR SET by Medical Engineering and Development Institute — Product Code GCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
May 4, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Medical Engineering and Development Institute

  • K902477 — WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET (August 24, 1990)
  • K902469 — BYRD DILATOR SHEATH SET - TEFLON (August 23, 1990)
  • K902502 — BYRD STAINLESS STEEL DILATOR (August 7, 1990)
  • K895030 — LIFE-LINE(TM) VASCULAR ACCESS SYSTEM (April 17, 1990)
  • K890820 — LOCKING WIRE GUIDE STYLET (March 22, 1989)

Other clearances for product code GCC

  • K981061 — INTRAVASCULAR RETRIEVAL DEVICE (May 26, 1998)
  • K922354 — BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET (July 30, 1992)
  • K902502 — BYRD STAINLESS STEEL DILATOR (August 7, 1990)
  • K820865 — VAN-TEC FASCIAL DILATOR (May 5, 1982)