PRODUCTS IMPLANTABLE PACING LEAD,TINED— 510(k) K823446

Name: FDA 510(k) clearance K823446
Creator: U.S. Food and Drug Administration
Published: 1982-12-03

Substantially Equivalent

Oscor, Inc.

FDA 510(k) clearance K823446 for PRODUCTS IMPLANTABLE PACING LEAD,TINED, Substantially Equivalent on 1982-12-03. Applicant: Oscor, Inc.. Device class: 3.

Clearance details

Applicant: Oscor, Inc.
Product code: Code DTB
Device class: Class 3
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 1982-11-16
Decision date: 1982-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harbor, FL, 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

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K151951 — Destino Reach2015-09-22
K143463 — IS4/DF4 Port Plug2015-03-19
K140917 — INTRODUCER, MODEL ADELANTE MAGNUM2014-07-09
K140406 — DESTINO TWIST, STEERABLE GUIDING SHEATH2014-04-17

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.