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510(k) K030662

PATHWAY ACCESS SHEATH CATHETER by Vertelink Corporation — Product Code EZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2003
Date Received
March 3, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Catheter, Ureteral
Device Class
Class II
Regulation Number
876.5470
Review Panel
GU
Submission Type

Other clearances by Vertelink Corporation

  • K032102 — VERTELINK KOBRA SPINAL FIXATION SYSTEM (December 12, 2003)
  • K030734 — PATHWAY ACCESS SHEATH CATHETER (September 10, 2003)

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