Agilis NxT Steerable Introducer Dual-Reach

FDA 510(k) Premarket Notification · Submission K243493 · Applicant: ABBOTT MEDICAL

Public Record 510(k) Submission Decision Date: 2024-12-13 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K243493.

Source Dataset
FDA 510(k) Premarket Notifications
510(k) Number
K243493
Applicant / Sponsor
Device Name
Agilis NxT Steerable Introducer Dual-Reach
Product Code
DYB
Decision Date
2024-12-13
Decision / Status
Substantially Equivalent (SESE)
Advisory Committee
Cardiovascular (CV)
Clearance Type
Special
Third Party Flag
N
Date Received
2024-11-12

Related Establishments / Registrations

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