FDA.reportPublic FDA data

InThrill Thrombectomy Catheter

Primary DI
00810123710126
Brand
InThrill Thrombectomy Catheter
Company
Inari Medical, Inc.
Model
43-102
Catalog number
43-102
Device description
InThrill Thrombectomy Catheter, 4-10mm, 8Fr, 65cm
Published
2025-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250421000InThrill™ Thrombectomy SystemInari Medical, Inc.2025-05-12QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850291007352PreviousGS10
00810123710126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850291007352008502910073528502910073520850291007352
00810123710126008101237101268101237101260810123710126

GMDN Terms#

Term, Definition table
TermDefinition
Electronic occlusion spectaclesA battery-powered ophthalmic device designed to test and train vision for conditions where decreased visual acuity may be due to unequal vision in the eyes (e.g., presbyopia). It is in the form of spectacles with lenses that can independently be made opaque electronically, so that the stronger eye is occluded to promote use of the weaker eye. It is intended to be used for short intervals (e.g., 15 – 30 minutes), typically at home, and is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
18779234747info@inarimedical.com

Regulatory Flags#

DUNS number
076827459
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850041730141LimFlow V-CeiverVC-US-232024-03-09
00850041730165LimFlow Crossing Stent GraftRGS-35060-US-242024-10-08
00850041730189LimFlow Extension Stent GraftRGS-55060-US-242024-10-08
00850041730196LimFlow Extension Stent GraftRGS-55100-US-242024-10-08
00850041730202LimFlow Extension Stent GraftRGS-55150-US-242024-10-08
00810123710140ClotTriever Catheter40-10240-1022024-04-17
00850291007475Triever LA Transseptal Sheath121-101121-1012024-04-15
00850041730134LimFlow VectorVT-US-232024-04-12
00810123710058ClotTriever SheathAS-0126150-1012023-12-15
00810123710430ClotTriever Sheath51-10151-1012023-12-15
00850291007123ClotTriever Sheath51-1012021-03-22
00850041730158LimFlow ARCAC-US-23AC-US-232024-04-19
00850291007697Large Bore 60 cc Syringe99-10299-1022024-12-20
00810123710577Artix Thin-Walled Sheath30-1042024-11-11
00810123710560Artix Thin-Walled Sheath30-10330-1032024-11-07
00850291007406VenaCore Thrombectomy Catheter46-10146-1012024-03-27
00850291007420FlowStasis Single-Pack70-10370-1032023-07-19
00850291007369InThrill Sheath53-10153-1012023-07-18
00850291007246FlowSaver80-10180-1012023-05-09
00850291007277ClotTriever XL Catheter41-10241-1022023-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-09-29
00850083646028enVast 6.0 x 35 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646042enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646059enVast 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646066enVast 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850044140015Helo Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-03-13
00810169722213Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722220Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722237Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722244Indigo SystemPENUMBRA, INC.QEW2026-03-10
00860008103819Recana Debulking CatheterIntervene, Inc.QEW2026-03-02
00860008103826Recana Collection Basket, 18mmIntervene, Inc.QEW2026-03-02
00860008103833Recana Collection Basket, 30mmIntervene, Inc.QEW2026-03-02
00860008103840Recana Introducer Sheath, 13Fr x 30cmIntervene, Inc.QEW2026-03-02
00860008103857Recana Introducer Sheath, 13Fr x 90cmIntervene, Inc.QEW2026-03-02
00860008103864Recana Introducer Sheath, 16Fr x 30cmIntervene, Inc.QEW2026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmIntervene, Inc.QEW2026-03-02
M917RVHD0RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
M917RVHD1RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
M917VRG7513B30RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
00810123710249Artix AXInari Medical, Inc.QEW2026-01-06
00810123710256Artix AXInari Medical, Inc.QEW2026-01-06
00810169722480Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722497Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722503Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722510Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722527Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722534Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722541Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722558Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24