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

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..

Clearance details

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

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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.