PUMP, BALLOON MODEL 10— 510(k) K781848

Substantially Equivalent

Avco Medical Products

FDA 510(k) clearance K781848 for PUMP, BALLOON MODEL 10, Substantially Equivalent on 1979-01-23. Applicant: Avco Medical Products.

Clearance details

Applicant: Avco Medical Products
Product code: Code DSP
Advisory panel: Cardiovascular
Date received: 1978-10-23
Decision date: 1979-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

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.