UNIPOLAR-E ENDOCARDIAL TINED LEAD— 510(k) K832245

Name: FDA 510(k) clearance K832245
Creator: U.S. Food and Drug Administration
Published: 1983-08-12

Substantially Equivalent

Cook Pacemaker Corp.

FDA 510(k) clearance K832245 for UNIPOLAR-E ENDOCARDIAL TINED LEAD, Substantially Equivalent on 1983-08-12. Applicant: Cook Pacemaker Corp.. Device class: 3.

Clearance details

Applicant: Cook Pacemaker Corp.
Product code: Code DTB
Device class: Class 3
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 1983-07-11
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTB

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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

More clearances from Cook Pacemaker Corp.

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K970690 — LOCKING STYLET 21997-05-20
K961992 — NEEDLE'S EYE SNARE1996-12-27
K953417 — MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS1995-09-29
K915188 — MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD1992-09-11
K905403 — MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER1991-10-16

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.