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510(k) K030662

PATHWAY ACCESS SHEATH CATHETER by Vertelink Corporation — Product Code EZN

K030662 is an FDA 510(k) premarket notification submitted by Vertelink Corporation for the device "PATHWAY ACCESS SHEATH CATHETER". The FDA issued a decision of Substantially Equivalent on September 3, 2003. The device falls under product code EZN (Dilator, Catheter, Ureteral), a Class II device regulated under 21 CFR 876.5470. Vertelink Corporation has at least 2 other 510(k) clearances on record.

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)

Other clearances for product code EZN

  • K250910 — Optilume® High Pressure Urological Balloon Dilation Catheter (May 22, 2025)
  • K220781 — ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz (May 5, 2023)
  • K201007 — In-Ka Ureteral Balloon Dilatation Catheter (June 11, 2020)
  • K190612 — EQUINOX Balloon Dilatation Catheter (December 6, 2019)
  • K173654 — Ureteral Dilator Sets, Ureteral Dilators (July 17, 2018)
  • K180756 — Safety Wire Guide Introducer (May 24, 2018)
  • K180028 — Cook 810 Set, Desilets-Hoffman Introducer Set (May 2, 2018)
  • K172588 — Balloon Catheter and Balloon Ureteral Dilator Set (April 19, 2018)
  • K170531 — Ureteral Dilators and Percutaneous Nephrostomy Dilators (August 17, 2017)
  • K132181 — GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER (October 21, 2013)

FDA data resources