MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB— 510(k) K030671

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K030671 for MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB, Substantially Equivalent on 2003-07-31. Applicant: Medtronic Vascular.

Clearance details

Applicant: Medtronic Vascular
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2003-03-03
Decision date: 2003-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.