MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH.— 510(k) K891611

Substantially Equivalent

Medtronic Versaflex, Inc.

FDA 510(k) clearance K891611 for MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH., Substantially Equivalent on 1989-06-12. Applicant: Medtronic Versaflex, Inc..

Clearance details

Applicant: Medtronic Versaflex, Inc.
Product code: Code LJT
Advisory panel: General Hospital
Date received: 1989-03-20
Decision date: 1989-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code LJT

product code LJT

Death: 234
Injury: 6,468
Malfunction: 5,326
Other: 2
Total: 12,030

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.