DeviceClearance

K080509

Substantially Equivalent

CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE

Applicant
Medtronic, Inc.
Product code
OCL
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Brooklyn Park, MN, US
Download summary PDF View on FDA.gov ↗

Adverse events under product code OCL

product code OCL
Death
34
Injury
256
Total
290

Source: openFDA MAUDE database, through . 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.