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510(k) K030734

PATHWAY ACCESS SHEATH CATHETER by Vertelink Corporation — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2003
Date Received
March 10, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Vertelink Corporation

  • K032102 — VERTELINK KOBRA SPINAL FIXATION SYSTEM (December 12, 2003)
  • K030662 — PATHWAY ACCESS SHEATH CATHETER (September 3, 2003)

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