ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS— 510(k) K895433

Name: FDA 510(k) clearance K895433
Creator: U.S. Food and Drug Administration
Published: 1990-04-10

Substantially Equivalent

Aries Medical, Inc.

FDA 510(k) clearance K895433 for ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS, Substantially Equivalent on 1990-04-10. Applicant: Aries Medical, Inc.. Device class: 2.

Clearance details

Applicant: Aries Medical, Inc.
Product code: Code DSP
Device class: Class 2
Regulation: 21 CFR 870.3535
Advisory panel: Cardiovascular
Date received: 1989-09-07
Decision date: 1990-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

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K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit2020-04-09
K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP)2019-11-12

More clearances from Aries Medical, Inc.

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K912604 — SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF1991-10-28
K903925 — ARIES MELDICAL MODEL 2100HC HANK CRANK1990-12-21
K903442 — ARIES TAPERSEAL(TM) SHEATH1990-08-23
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 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.