HEART PACK II— 510(k) K914935

Clearance details

Applicant

Westmark Hospital Supplies

Product code

Code LRO

Device class

Class 2

Regulation

21 CFR 878.4370

Advisory panel

General, Plastic Surgery

Date received

1991-11-04

Decision date

1992-01-31

Decision

Unknown

Clearance type

Traditional

Location

Grand Rapids, MI, US

• K213481 — Medline General Surgery Tray2022-05-24
• K212258 — Medline Cardiovascular Procedure Kit2021-12-03
• K041080 — SURGICAL DRAPE KIT - D.I.R.R.A. SRL2004-11-30
• K030721 — QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE2003-03-31
• K023276 — AMSINO TRACHEOSTOMY CARE TRAY2002-12-09

• K914934 — HAND PACK1993-01-21
• K914928 — BASIC SET UP TRAY1992-03-16
• K914927 — DRESSING CHANGE KIT1992-01-31
• K914929 — LACERATION TRAY1992-01-31
• K914932 — SUTURE REMOVAL KIT1992-01-31

Injury

975

Malfunction

14,038

Other

2

Total

15,015

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →