CORLINK AAD - M

510(k) K011589

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 11 Oct 2026

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK011589	Date26 Dec 2001Cleared	StatusActive

0 recalls · FDA

No FDA recalls found in the data synced 11 Oct 2026.

1 jurisdiction

United States — FDA 510(k) Active

510(k)

510(k) Number: K011589
FDA Product Code: NCA
Models / Variants: 200-064
Corlink Aad (2.0 To 4.0 Mm Outer Diameter Vessels)
M
FDA applicant: Bypass , Ltd.