MEDI-TECH PLATFORM GUIDE CATHETER— 510(k) K952345

Name: FDA 510(k) clearance K952345
Creator: U.S. Food and Drug Administration
Published: 1995-08-17

Substantially Equivalent

Medi-Tech, Inc.

FDA 510(k) clearance K952345 for MEDI-TECH PLATFORM GUIDE CATHETER, Substantially Equivalent on 1995-08-17. Applicant: Medi-Tech, Inc.. Device class: 2.

Clearance details

Applicant: Medi-Tech, Inc.
Product code: Code DQY
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 1995-05-19
Decision date: 1995-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.