Class Class II

Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K242504)

K242504 2024-09-20 Special
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Description

Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set by Perfuze, Ltd., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242504
Clearance Date2024-09-20
Clearance TypeSpecial
Product CodeNRY
Regulation Number870.1250

Categories

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Predicate lineage for K242504

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set (K242504) cites 2 predicate devices and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K233648Millipede 088 Access CatheterPerfuze, Ltd.2023
K232524Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.2023

Later devices that cite this one as their predicate

Devices that cite K242504
K numberDeviceApplicantYear
K250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetPerfuze, Ltd.2025

Trace the full predicate network for K242504

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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