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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 (AS-01403) FDA UDI
Model / Reference
53-101 FDA UDI
Description
InThrill Sheath (AS-01403) FDA UDI

Identifiers

Catalog Number
53-101 FDA UDI
Primary DI / UDI-DI
00810123710294 FDA UDI
510(k) Number
K250421 FDA UDI
FDA Product Code
QEW FDA UDI
GMDN Term
Thrombectomy wire-net introduction set FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

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.

Cleared under the same submission

K250421 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inari Medical, Inc.

Sources (1)

  • FDA UDI 59a0da53-b7c4-4490-9393-6283d89c8295 36 fields · synced May 30, 2026