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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX

Manufacturer

ST. JUDE MEDICAL

Date Cleared

2000-12-22

(88 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

K012708,K022380,K030026,K030114,K133028,K151622,K161272,K161769,K161827

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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