K864507

Substantially Equivalent

V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540

Applicant: Spectramed, Inc.
Product code: LDF
Advisory panel: Cardiovascular
Date received: 1986-11-14
Decision date: 1987-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Findley, MN, US

Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.