InThrill Sheath

FDA UDI

Class II (US FDA UDI)

by Inari Medical, Inc.

Identity

Trade Name: InThrill Sheath FDA UDI
Generic Name: Thrombectomy wire-net introduction set FDA UDI
Device Name: InThrill Sheath (InThrill Thrombectomy System) FDA UDI
Model / Reference: 53-101 FDA UDI
Description: InThrill Sheath (InThrill Thrombectomy System) FDA UDI

Identifiers

Catalog Number: 53-101 FDA UDI
Primary DI / UDI-DI: 00850291007369 FDA UDI
510(k) Number: K220887 FDA UDI
K223613 FDA UDI
FDA Product Code: KRA FDA UDI
QEW FDA UDI
GMDN Term: Thrombectomy wire-net introduction set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1210 FDA UDI
870.5150 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Thrombectomy wire-net introduction set

InThrill Sheath by Inari Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thrombectomy wire-net introduction set.

Protrieve Sheath — Inari Medical, Inc. · Class II
ClotTriever Sheath, 16 Fr — Inari Medical, Inc. · Class II
InThrill Sheath — Inari Medical, Inc. · Class II
ClotTriever Sheath, 13 Fr — Inari Medical, Inc. · Class II
Triever LA Transseptal Sheath — Inari Medical, Inc. · Class II

Cleared under the same submission

K220887 also covers:

InThrill Thrombectomy Catheter — Inari Medical, Inc.

K223613 also covers:

InThrill Thrombectomy Catheter — Inari Medical, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Inari Medical, Inc.

Sources (1)

FDA UDI 0eddab9f-156e-4dd7-be1b-15bd4e4fdb3e 36 fields · synced Jun 1, 2026