PACIFIC XTREME PTCA BALLOON DILATATION CATHETER— 510(k) K103464

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K103464 for PACIFIC XTREME PTCA BALLOON DILATATION CATHETER, Substantially Equivalent on 2010-12-22. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2010-11-24
Decision date: 2010-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Danvers, MA, US

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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.