NAVIGATOR— 510(k) K853747

Name: FDA 510(k) clearance K853747
Creator: U.S. Food and Drug Administration
Published: 1986-01-08

Substantially Equivalent

Mainsfield Scientific, Inc.

FDA 510(k) clearance K853747 for NAVIGATOR, Substantially Equivalent on 1986-01-08. Applicant: Mainsfield Scientific, Inc.. Device class: 3.

Clearance details

Applicant: Mainsfield Scientific, Inc.
Product code: Code DTB
Device class: Class 3
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 1985-09-09
Decision date: 1986-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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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

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.