FUTURECARE CARELYNK IV SYSTEM— 510(k) K903512

Substantially Equivalent

Futurecare Systems, Inc.

FDA 510(k) clearance K903512 for FUTURECARE CARELYNK IV SYSTEM, Substantially Equivalent on 1991-07-18. Applicant: Futurecare Systems, Inc..

Clearance details

Applicant: Futurecare Systems, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1990-08-03
Decision date: 1991-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden Hills, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.