MANIFOLD— 510(k) K972654

Name: FDA 510(k) clearance K972654
Creator: U.S. Food and Drug Administration
Published: 1997-10-08

Substantially Equivalent

Medical Specialties Intl., Inc.

FDA 510(k) clearance K972654 for MANIFOLD, Substantially Equivalent on 1997-10-08. Applicant: Medical Specialties Intl., Inc.. Device class: 2.

Clearance details

Applicant: Medical Specialties Intl., Inc.
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 1997-07-15
Decision date: 1997-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarpon Springs, FL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.