Heartvista, Inc.

FDA Regulatory Profile

Heartvista, Inc. has 0 FDA recalls, 0 inspections, 6 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Oct 5, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances6Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K212233RTHawk, HeartVista Cardiac PackageOct 5, 2021
K183274RTHawk, HeartVista Cardiac PackageOct 18, 2019
K170090RTHawk, HeartVista Cardiac PackageJul 14, 2017
K153740RTHawk, HeartVista Cardiac PackageJun 30, 2016
K142997RTHawk, HeartVista Workstation with RTHawkDec 17, 2014
K133848RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWKJun 25, 2014