Home / 510(k) Clearances / K914933

510(k) K914933

HEART PACK III by Westmark Hospital Supplies — Product Code KOD

K914933 is an FDA 510(k) premarket notification submitted by Westmark Hospital Supplies for the device "HEART PACK III". The FDA issued a decision of Substantially Equivalent (kit, denovo) on January 31, 1992. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Westmark Hospital Supplies has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
January 31, 1992
Date Received
November 4, 1991
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 Westmark Hospital Supplies

  • K914934 — HAND PACK (January 21, 1993)
  • K914928 — BASIC SET UP TRAY (March 16, 1992)
  • K914927 — DRESSING CHANGE KIT (January 31, 1992)
  • K914935 — HEART PACK II (January 31, 1992)
  • K914929 — LACERATION TRAY (January 31, 1992)
  • K914932 — SUTURE REMOVAL KIT (January 31, 1992)

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)

FDA data resources