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510(k) K813278

VPI URETERAL DILATATION BALLON CATHETER by Vance Products, Inc. — Product Code EZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1981
Date Received
November 23, 1981
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 Vance Products, Inc.

  • K820313 — VPI-FAIR URETHRAL STENT (March 1, 1982)
  • K812995 — VANCE-JACOBELLIS MICROHEMATURIA CATHETER (March 1, 1982)
  • K812785 — VANCE-AMBROSE RESECTOSCOPE FORCEPS (November 16, 1981)
  • K812057 — VANCE CYSTOSCOPIC (July 31, 1981)
  • K811833 — VNACE FASCIAL DILATOR SET (July 10, 1981)
  • K811454 — VANCE PROSTATIC ASPIRATION SET (June 9, 1981)
  • K810372 — VANCE DEFLECTABLE BIOPSY BRUSH SET (March 20, 1981)
  • K810367 — KISH URETHRAL ILLUMINATED CATHETER SET (March 20, 1981)
  • K810368 — VANCE PERCUTANEOUS MALECOT NEPHROSTOMY (March 20, 1981)
  • K810370 — POLLACK CHAIN CYSOURETHROGRAM SET (March 20, 1981)

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  • 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)