510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Inari Medical, Inc.

Irvine, CA, US

Inari Medical, Inc. appears in FDA device records in Irvine, CA. FDA records list 56 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
56
PMA records
0
Recall records
3
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Inari Medical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Inari Medical - Oak Canyonenforcement report, recall

510(k) clearance history

Showing 50 of 56

FDA records hold 56 510(k) clearances for Inari Medical, Inc. between 2015 and 2025. The busiest year on record is 2023, with 16. The most recent is 2025, with 4.

Clearances by year, as a table
510(k) clearance decisions for Inari Medical, Inc., by decision year
YearClearances
20152
20161
20172
20188
20194
20204
20215
20226
202316
20244
20254
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252508Intri26 Introducer SheathDYBSubstantially Equivalent
K253323Protrieve SheathQEWSubstantially Equivalent
K250421InThrill™ Thrombectomy SystemQEWSubstantially Equivalent
K250088FlowTriever2 CatheterQEWSubstantially Equivalent
K241894Artix™ MT; Artix™ Thin-Walled Thrombectomy SheathQEWSubstantially Equivalent
K242557ClotTriever XL Catheter (41-102)QEWSubstantially Equivalent
K233069Removal System Large Bore 60 cc SyringePURSubstantially Equivalent
K234034VenaCore Thrombectomy Catheter (46-101)QEWSubstantially Equivalent
K233815ClotTriever SheathQEWSubstantially Equivalent
K233646Intri24 Introducer Sheath (52-101)DYBSubstantially Equivalent
K231108Talon Transseptal SheathDYBSubstantially Equivalent
K231848Triever20 Curve (21-201)QEWSubstantially Equivalent
K231782FlowSaver Blood Return System (80-101)CACSubstantially Equivalent
K230912Artix BGQEWSubstantially Equivalent
K223210ClotTriever XL CatheterQEWSubstantially Equivalent
K230494ClotTriever BOLD CatheterQEWSubstantially Equivalent
K223419Triever16 CurveQEWSubstantially Equivalent
K223613InThrill Thrombectomy SystemQEWSubstantially Equivalent
K223609RevCore™ Thrombectomy Catheter.QEWSubstantially Equivalent
K230331Protrieve SheathQEWSubstantially Equivalent
K223436Artix AXQEWSubstantially Equivalent
K221483FlowSaver Blood Return SystemCACSubstantially Equivalent
K221531ClotTriever Thrombectomy SystemQEWSubstantially Equivalent
K223000Artix BGQEWSubstantially Equivalent
K220887Mini-ClotTriever Thrombectomy SystemQEWSubstantially Equivalent
K220415Protrieve SheathQEWSubstantially Equivalent
K221846Artix Ballon Guiding SheathDQYSubstantially Equivalent
K213402Triever24, Triever20QEWSubstantially Equivalent
K212392Intri24 SheathDYBSubstantially Equivalent
K220600Artix Thrombectomy DeviceQEWSubstantially Equivalent
K212632ClotTriever Thrombectomy SystemQEWSubstantially Equivalent
K210176FlowSaver Blood FilterCACSubstantially Equivalent
K210689ClotTriever Thrombectomy SystemQEWSubstantially Equivalent
K211013FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24QEWSubstantially Equivalent
K210195Triever CathetersQEWSubstantially Equivalent
K202345FlowTriever Retrieval/Aspiration SystemQEWSubstantially Equivalent
K203333Triever20 Curve CatheterQEWSubstantially Equivalent
K201541FlowTriever Retrieval/Aspiration SystemQEWSubstantially Equivalent
K193462ClotTriever Thrombectomy SystemQEWSubstantially Equivalent
K192332ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever SheathQEWSubstantially Equivalent
K191710FlowTriever Retrieval/Aspiration SystemQEWSubstantially Equivalent
K192036ClotTriever Thrombectomy SystemQEWSubstantially Equivalent
K191368FlowTriever Retrieval/Aspiration SystemQEWSubstantially Equivalent
K183198FlowTriever Retrieval/Aspiration SystemQEWSubstantially Equivalent
K182233FlowTriever Retrieval/Aspiration SystemQEWSubstantially Equivalent
K182531ClotTriever Thrombectomy SystemQEWSubstantially Equivalent
K181694FlowTriever Retrieval/Aspiration SystemQEWSubstantially Equivalent
K181325FlowTriever Retrieval/Aspiration SystemQEWSubstantially Equivalent
K180466FlowTriever Retrieval/Aspiration SystemQEWSubstantially Equivalent
K180329ClotTriever Thrombectomy SystemQEWSubstantially Equivalent

Registered establishments

FDA registered establishments for Inari Medical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30203472183020347218Inari Medical, Inc.6001 Oak Canyon, Suite 100, Irvine, CA 92618 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1728-2025Artix MT Thrombectomy Device, REF: 32-102Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.Class IIOpen, Classified
Z-2587-2024ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.Class IOpen, Classified
Z-2299-2020Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/ Aspiration System, UDI: 00850291007079The hemostasis valve of aspiration guide catheter devices may fail to seal resulting in a loss of vacuum during thrombus aspiration, which may result the procedure being prolonged as another device must be used or suboptimal thrombus removal if the problem is not detected.Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain