KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000— 510(k) K892878

Name: FDA 510(k) clearance K892878
Creator: U.S. Food and Drug Administration
Published: 1989-09-13

Substantially Equivalent

Kontron Instruments, Inc.

FDA 510(k) clearance K892878 for KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000, Substantially Equivalent on 1989-09-13. Applicant: Kontron Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Kontron Instruments, Inc.
Product code: Code DSP
Device class: Class 2
Regulation: 21 CFR 870.3535
Advisory panel: Cardiovascular
Date received: 1989-04-19
Decision date: 1989-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Everett, MA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Kontron Instruments, Inc.

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K932268 — MODIFICATIONS TO INTRA-AORTIC BALLOONS1993-12-15
K925248 — MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS1993-09-27
K923603 — INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION1993-03-08
K905313 — KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II1991-06-19
K903344 — 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)1991-01-15

Adverse events under product code DSP

product code DSP

Death: 317
Injury: 566
Malfunction: 36,831
Other: 4
Total: 37,718

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.