Triever LA Transseptal Sheath 121-101

GUDID 00850291007475

Triever LA Transseptal Sheath

INARI MEDICAL INC

Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set Thrombectomy wire-net introduction set

• Primary Device ID: 00850291007475
• NIH Device Record Key: c9d9dde4-44dd-45b4-b6e0-e02856c339f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triever LA Transseptal Sheath
• Version Model Number: 121-101/ AS-01084
• Catalog Number: 121-101
• Company DUNS: 076827459
• Company Name: INARI MEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850291007475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231108

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-23
• Device Publish Date: 2024-04-15

Devices Manufactured by INARI MEDICAL INC

• 00810123710096 - Triever24: 2024-04-25
• 00810123710140 - ClotTriever Catheter: 2024-04-25 ClotTriever, 16mm
• 00810123710065 - Triever20: 2024-04-24 Triever20
• 00850291007475 - Triever LA Transseptal Sheath: 2024-04-23Triever LA Transseptal Sheath
• 00850291007475 - Triever LA Transseptal Sheath: 2024-04-23 Triever LA Transseptal Sheath
• 00850291007406 - VenaCore Thrombectomy Catheter: 2024-04-04 VenaCore Thrombectomy Catheter
• 00810123710058 - ClotTriever Sheath, 13 Fr: 2023-12-25 ClotTriever Sheath, 13 Fr (ClotTriever Thrombectomy System)
• 00810123710430 - ClotTriever Sheath, 16 Fr: 2023-12-25 ClotTriever Sheath, 16 Fr (ClotTriever Thrombectomy System)
• 00810123710522 - Triever20 Curve: 2023-12-25 Triever20 Curve