HEART PACK II— 510(k) K914935

Unknown

Westmark Hospital Supplies

FDA 510(k) clearance K914935 for HEART PACK II, Unknown on 1992-01-31. Applicant: Westmark Hospital Supplies.

Clearance details

Applicant: Westmark Hospital Supplies
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 1991-11-04
Decision date: 1992-01-31
Decision: Unknown
Clearance type: Traditional
Location: Grand Rapids, MI, US

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Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.