CHASE CARDIOVASCULAR PATCH KIT— 510(k) K020233

Name: FDA 510(k) clearance K020233
Creator: U.S. Food and Drug Administration
Published: 2002-03-14

Substantially Equivalent

Chase Medical, Inc.

FDA 510(k) clearance K020233 for CHASE CARDIOVASCULAR PATCH KIT, Substantially Equivalent on 2002-03-14. Applicant: Chase Medical, Inc.. Device class: 2.

Clearance details

Applicant: Chase Medical, Inc.
Product code: Code DXZ
Device class: Class 2
Regulation: 21 CFR 870.3470
Advisory panel: Cardiovascular
Date received: 2002-01-23
Decision date: 2002-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, US

Download summary PDF View on FDA.gov ↗

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K162506 — PhotoFix Decellularized Bovine Pericardium2017-03-09
K162579 — VascuCel2016-10-14
K152127 — CorMatrix Tyke2016-02-04

More clearances from Chase Medical, Inc.

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K032531 — CHASE CARDIAC ANALYSIS SYSTEM2004-02-02
K022093 — CHASE CARDIOVASCULAR PATCH KIT2002-09-20
K021129 — CHARE CARIOVASCULAR PATCH2002-06-03
K020132 — CHASE CARDIOVASCULAR PATCH KIT2002-02-26
K012248 — CHASE CARDIOVASCULAR PATCH2001-08-10

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.