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510(k) K895030

LIFE-LINE(TM) VASCULAR ACCESS SYSTEM by Medical Engineering and Development Institute — Product Code LJT

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 17, 1990
Date Received
August 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

Other clearances by Medical Engineering and Development Institute

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  • K902469 — BYRD DILATOR SHEATH SET - TEFLON (August 23, 1990)
  • K902502 — BYRD STAINLESS STEEL DILATOR (August 7, 1990)
  • K893480 — BYRD EXTRACTOR SET (June 23, 1989)
  • K890820 — LOCKING WIRE GUIDE STYLET (March 22, 1989)

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