Coronary Infusion Kit

by Mallinckrodt Critical Care 510(k)

Active United States

510(k) K822640

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK822640	Date28 Sep 1982Cleared	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Withdrawn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: K822640
FDA Product Code: DQO

Device Class: Class II
Regulation: 21 CFR Part 870.1200
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

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