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510(k) K902502

BYRD STAINLESS STEEL DILATOR by Medical Engineering and Development Institute — Product Code GCC

K902502 is an FDA 510(k) premarket notification submitted by Medical Engineering and Development Institute for the device "BYRD STAINLESS STEEL DILATOR". The FDA issued a decision of Substantially Equivalent on August 7, 1990. The device falls under product code GCC (Dilator, Catheter), a Class I device regulated under 21 CFR 878.4200. Medical Engineering and Development Institute has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1990
Date Received
June 5, 1990
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)
  • 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)

Other clearances for product code GCC

  • K981061 — INTRAVASCULAR RETRIEVAL DEVICE (May 26, 1998)
  • K922354 — BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET (July 30, 1992)
  • K893480 — BYRD EXTRACTOR SET (June 23, 1989)
  • K820865 — VAN-TEC FASCIAL DILATOR (May 5, 1982)

FDA data resources