TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100— 510(k) K904748

Name: FDA 510(k) clearance K904748
Creator: U.S. Food and Drug Administration
Published: 1991-03-01

Substantially Equivalent

Transtracheal Systems

FDA 510(k) clearance K904748 for TRANSKINETICS INFRARED MULTI-LEAD TELE SYST 7100, Substantially Equivalent on 1991-03-01. Applicant: Transtracheal Systems. Device class: 2.

Clearance details

Applicant: Transtracheal Systems
Product code: Code DRG
Device class: Class 2
Regulation: 21 CFR 870.2910
Advisory panel: Cardiovascular
Date received: 1990-10-19
Decision date: 1991-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRG

product code DRG

Death: 5
Total: 5

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.