CREATIVE CARE SYSTEMS' IV START KIT— 510(k) K863796

Name: FDA 510(k) clearance K863796
Creator: U.S. Food and Drug Administration
Published: 1986-11-28

Substantially Equivalent

American Biomaterials Corp.

FDA 510(k) clearance K863796 for CREATIVE CARE SYSTEMS' IV START KIT, Substantially Equivalent on 1986-11-28. Applicant: American Biomaterials Corp.. Device class: 2.

Clearance details

Applicant: American Biomaterials Corp.
Product code: Code LRS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1986-09-29
Decision date: 1986-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRS

view all

K050654 — AMSINO I.V. START KIT2005-05-02
K001879 — INFUSION IV SET2001-11-20
K963722 — IV START KIT1996-11-27
K951167 — EMS I.V. START KIT1995-05-16
K950184 — B. BRAUN IV START KITS1995-03-15

More clearances from American Biomaterials Corp.

view all

K922455 — EVERT-O-CATH CATHETER1994-07-07
K924725 — AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTS1993-02-05
K915824 — HOLE PUNCH1993-01-29
K880371 — BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER1988-11-18
K843461 — BIOGLASS OSSICULAR RECONSTRUCTION PROSTH1985-01-09

Adverse events under product code LRS

product code LRS

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.