Class Class II

CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K221934)

K221934 2023-03-09 Traditional
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Description

CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set by Cerenovus, Inc., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK221934
Clearance Date2023-03-09
Clearance TypeTraditional
Product CodeNRY
Regulation Number870.1250

Categories

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Predicate lineage for K221934

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. CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tubing Set (K221934) cites 1 predicate device and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetCodman & Shurtleff, Inc.2020

Later devices that cite this one as their predicate

Devices that cite K221934
K numberDeviceApplicantYear
K251828CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing SetCerenovus, Inc.2025

Trace the full predicate network for K221934

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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