ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP— 510(k) K852446

Name: FDA 510(k) clearance K852446
Creator: U.S. Food and Drug Administration
Published: 1985-09-17

Substantially Equivalent

Diag Corp.

FDA 510(k) clearance K852446 for ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP, Substantially Equivalent on 1985-09-17. Applicant: Diag Corp.. Device class: 3.

Clearance details

Applicant: Diag Corp.
Product code: Code DTB
Device class: Class 3
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 1985-06-10
Decision date: 1985-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minnetonka, MN, 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 Diag Corp.

view all

K984062 — SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 4062291999-03-24
K911883 — DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER1991-11-29
K910645 — DISPOSABLE PATIENT CABLE1991-05-07
K820003 — CARDIOVASCULAR TEMP. PACEMAKER ELEC1982-03-26
K820262 — PERMANENT & TEMPORARY PACEMAKER ELECTR.1982-03-12

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.