Atlas FDA

Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)

FDA 510(k) clearance K241370 · decided 2024-06-13

Clearance details

K-number
K241370
Device name
Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED)
Applicant
ABBOTT MEDICAL
Decision
Substantially Equivalent
Date received
2024-05-14
Decision date
2024-06-13
Days to decision
30 days
Clearance type
Special
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Minnetonka, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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