SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143— 510(k) K980869

Name: FDA 510(k) clearance K980869
Creator: U.S. Food and Drug Administration
Published: 1998-09-10

Substantially Equivalent

Biotronik, Inc.

FDA 510(k) clearance K980869 for SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143, Substantially Equivalent on 1998-09-10. Applicant: Biotronik, Inc.. Device class: 3.

Clearance details

Applicant: Biotronik, Inc.
Product code: Code DTB
Device class: Class 3
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 1998-03-06
Decision date: 1998-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Oswego, OR, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DTB

product code DTB

Death: 1,491
Injury: 67,311
Malfunction: 79,368
Other: 10
Total: 148,180

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.