IVEX-2 EXTENSION SET WITH Y-INJECTION SITE— 510(k) K941684

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K941684 for IVEX-2 EXTENSION SET WITH Y-INJECTION SITE, Substantially Equivalent on 1994-08-03. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code FPB
Advisory panel: General Hospital
Date received: 1994-04-04
Decision date: 1994-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

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Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

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.