HANCOCK PERICARDIAL PATCH— 510(k) K840262

Name: FDA 510(k) clearance K840262
Creator: U.S. Food and Drug Administration
Published: 1984-05-30

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K840262 for HANCOCK PERICARDIAL PATCH, Substantially Equivalent on 1984-05-30. Applicant: Extracorporeal Medical Specialities, Inc.. Device class: 2.

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code DXZ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 1984-01-19
Decision date: 1984-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K152127 — CorMatrix Tyke2016-02-04

More clearances from Extracorporeal Medical Specialities, Inc.

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K843955 — EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR1984-11-29
K840532 — HEMOPERFUSION SYSTEM TP-4001984-05-30
K840057 — EXP* 500 PARALLEL PLATE DIALYZER1984-02-04
K840146 — EXP* 700 PARALLEL PLATE DIALYZER1984-02-04
K831423 — THERAPEUTIC EXCHANGE SYSTEM1984-01-03

Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.