FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)— 510(k) K051519

Substantially Equivalent

Abbott Laboratories (Perclose, Inc.)

FDA 510(k) clearance K051519 for FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES), Substantially Equivalent on 2005-06-21. Applicant: Abbott Laboratories (Perclose, Inc.). Device class: 2.

Clearance details

Applicant: Abbott Laboratories (Perclose, Inc.)
Product code: Code LIT
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2005-06-08
Decision date: 2005-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Redwood, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.