SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF— 510(k) K912604

Name: FDA 510(k) clearance K912604
Creator: U.S. Food and Drug Administration
Published: 1991-10-28

Substantially Equivalent

Aries Medical, Inc.

FDA 510(k) clearance K912604 for SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF, Substantially Equivalent on 1991-10-28. Applicant: Aries Medical, Inc.. Device class: 2.

Clearance details

Applicant: Aries Medical, Inc.
Product code: Code KFM
Device class: Class 2
Regulation: 21 CFR 870.4360
Advisory panel: Cardiovascular
Date received: 1991-05-31
Decision date: 1991-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelmsford, MA, US

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K895433 — ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS1990-04-10
K882289 — ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH.1988-12-12
K864537 — 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER1987-06-19

Adverse events under product code KFM

product code KFM

Death: 109
Injury: 241
Malfunction: 1,779
Total: 2,129

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.