TandemLung Oxygenator

by Cardiacassist, Inc. 510(k)

Active United States

510(k) K153295

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK153295	Date26 Feb 2016Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K153295
FDA Product Code: DTZ

Device Class: Class II
Regulation: 21 CFR Part 870.4350
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

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