Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED)— 510(k) K241370

Name: FDA 510(k) clearance K241370
Creator: U.S. Food and Drug Administration
Published: 2024-06-13

Substantially Equivalent

ABBOTT MEDICAL

FDA 510(k) clearance K241370 for Agilis NxT Steerable Introducer Dual-Reach (I-V2-MED), Substantially Equivalent on 2024-06-13. Applicant: ABBOTT MEDICAL. Device class: 2.

Clearance details

Applicant: ABBOTT MEDICAL
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2024-05-14
Decision date: 2024-06-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Minnetonka, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYB

view all

K253526 — NAMIC Dilator and Sheath2026-07-29
K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C) +2 more2026-07-06
K261242 — SimplGuide2026-06-25
K261950 — Health Line Tearaway Introducer2026-06-22
K261492 — FieldFlex Steerable Sheath2026-06-05

More clearances from ABBOTT MEDICAL

view all

K262006 — EnSite X EP System2026-07-15
K261631 — Amplatzer TorqVue Exchange System2026-06-17
K253459 — OPTIS Mobile Next Imaging System (1014932) +2 more2026-04-24
K260212 — EnSite X EP System2026-04-20
K253907 — Disposable Radiofrequency Cannula2026-04-16

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.