STOCKERT COMPACT SYSTEM— 510(k) K982014

Name: FDA 510(k) clearance K982014
Creator: U.S. Food and Drug Administration
Published: 1998-09-04

Substantially Equivalent

Stoeckert Instrumente

FDA 510(k) clearance K982014 for STOCKERT COMPACT SYSTEM, Substantially Equivalent on 1998-09-04. Applicant: Stoeckert Instrumente. Device class: 2.

Clearance details

Applicant: Stoeckert Instrumente
Product code: Code DTQ
Device class: Class 2
Regulation: 21 CFR 870.4220
Advisory panel: Cardiovascular
Date received: 1998-06-08
Decision date: 1998-09-04
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTQ

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K232291 — Essenz HLM, Essenz ILBM2023-08-24
K221895 — Terumo Advanced Perfusion System 12023-04-18
K221373 — Essenz HLM2023-03-09
K210130 — Stockert S5 System2021-04-05
K202125 — Century Perfusion System2021-03-07

More clearances from Stoeckert Instrumente

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K002273 — STOCKERT A272 SERIES PEDIATRIC AORTIC CANNULAE2001-01-29
K001961 — STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE2001-01-25
K002118 — STOCKERT COMPACT SYSTEM VERSION 2.02000-08-09
K992635 — INTERFACE MODULE IDDD1999-12-20
K990512 — STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS1999-11-23

Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

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.