Coolgard 3000

by Alsius Corp.

510(k) K060308

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 9 Oct 2026

Documents

510(k) K060308↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESU Traditional	NumberK060308	Date26 Apr 2006Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 9 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K060308
FDA Product Code: NCX

Device Class: Class II
Regulation: 21 CFR Part 870.5900
Advisory Committee: Cardiovascular
FDA Decision: SESU

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