IV START KIT— 510(k) K963722

Clearance details

Applicant

Grand Medical Products

Product code

Code LRS

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1996-09-16

Decision date

1996-11-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Schaumburg, IL, US

• K050654 — AMSINO I.V. START KIT2005-05-02
• K001879 — INFUSION IV SET2001-11-20
• K951167 — EMS I.V. START KIT1995-05-16
• K950184 — B. BRAUN IV START KITS1995-03-15
• K944041 — PERSONAL HEARING SYSTEM1994-12-27

• K963724 — GAUZE SPONGE, NON X-RAY DETECTABLE1996-11-29
• K963714 — GRAND MEDICAL SUTURE REMOVAL KIT1996-11-27
• K963715 — DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY1996-11-27
• K963719 — CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY1996-11-27
• K963720 — TRACHEOSTOMY KIT1996-11-27

Other

2

Total

2

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 →