Home / 510(k) Clearances / K812995

510(k) K812995

VANCE-JACOBELLIS MICROHEMATURIA CATHETER by Vance Products, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1982
Date Received
October 26, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Vance Products, Inc.

  • K820313 — VPI-FAIR URETHRAL STENT (March 1, 1982)
  • K813278 — VPI URETERAL DILATATION BALLON CATHETER (December 18, 1981)
  • 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)
  • K810371 — VANCE URETHAL DILATOR SET (March 20, 1981)
  • K810370 — POLLACK CHAIN CYSOURETHROGRAM SET (March 20, 1981)
  • K810368 — VANCE PERCUTANEOUS MALECOT NEPHROSTOMY (March 20, 1981)
  • K810367 — KISH URETHRAL ILLUMINATED CATHETER SET (March 20, 1981)

Other clearances for product code KOD

  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K220036 — Wellead Ureteral Catheter (December 16, 2022)
  • K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters (October 13, 2022)
  • K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (November 19, 2021)
  • K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 2019)
  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
  • K181144 — Angled Tip Ureteral Catheter (June 28, 2018)
  • K180530 — Imager II Urology Torque Catheter (April 10, 2018)
  • K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (March 7, 2018)
  • K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter (February 16, 2018)