Class Class II

SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (K220981)

K220981 2023-04-20 Traditional
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Description

SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe by Fehling Surgical Instruments, Inc., an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK220981
Clearance Date2023-04-20
Clearance TypeTraditional
Product CodeDWP
Regulation Number870.4475

Categories

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Predicate lineage for K220981

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. SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe (K220981) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K183438Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co.2019

Trace the full predicate network for K220981

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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