Kontron Intra-Aortic Balloon Pump Model K9000

by Kontron Instruments, Inc. 510(k)

Active United States

510(k) K892878

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK892878	Date13 Sep 1989Cleared	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Withdrawn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 11 Oct 2026.

Specification

510(k)

510(k) Number: K892878
FDA Product Code: DSP

Device Class: Class II
Regulation: 21 CFR Part 870.3535
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

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