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Keystone Heart, Ltd.

FDA Regulatory Profile

Keystone Heart, Ltd. has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Oct 29, 2020 · VAI
Latest 510(k)
Dec 15, 2020

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections1Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 29, 2020Tampa, FLDevicesVoluntary Action Indicated (VAI)3012609179

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K202226Lim Precision Steerable TS, Steerable Sheath, DilatorDec 15, 2020

FDA data resources