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TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 — Cardiacassist, Inc. (510(k) K052570)

TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 — Cardiacassist, Inc. (510(k) K052570) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221; Applicant: Cardiacassist, Inc.; Clearance track: 510(k).

Device nameTANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
ApplicantCardiacassist, Inc.
Clearance track510(k)
Submission numberK052570
DecisionSubstantially Equivalent
Decision date2006-01-17
Date received2005-09-19
Product codeDWF
Device class2
Medical specialtyCardiovascular
Applicant locationPA, US
SourceopenFDA device

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