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510(k) Data Aggregation

K Number

Device Name

Zoom System (Zoom 4S Catheter)

Manufacturer

Imperative Care, Inc.

Date Cleared

2025-10-30

(122 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

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N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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