ENDOCARDIAL BIPOLAR LEAD— 510(k) K781456

Name: FDA 510(k) clearance K781456
Creator: U.S. Food and Drug Administration
Published: 1978-12-04

Substantially Equivalent

American Technology, Inc.

FDA 510(k) clearance K781456 for ENDOCARDIAL BIPOLAR LEAD, Substantially Equivalent on 1978-12-04. Applicant: American Technology, Inc.. Device class: 3.

Clearance details

Applicant: American Technology, Inc.
Product code: Code DTB
Device class: Class 3
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 1978-08-23
Decision date: 1978-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTB

view all

K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS2006-07-10
K041809 — PERMANENT PACING LEAD, MODEL PY22004-08-06
K040569 — PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU2004-04-07
K031274 — MODEL 5071 MYOCARDIAL PACING LEAD2003-05-22
K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD2003-05-16

More clearances from American Technology, Inc.

view all

K781326 — UNIPOPLAR ENDOCARDIAL LEADS1978-12-04
K771528 — CATHETER, CARDIAC PACING, ENDOCARDIAL1977-08-16

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.