OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR— 510(k) K964107

Name: FDA 510(k) clearance K964107
Creator: U.S. Food and Drug Administration
Published: 1997-04-01

Substantially Equivalent - Subject to Tracking & PMS

Oscor Medical Corp.

FDA 510(k) clearance K964107 for OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR, Substantially Equivalent - Subject to Tracking & PMS on 1997-04-01. Applicant: Oscor Medical Corp.. Device class: 3.

Clearance details

Applicant: Oscor Medical Corp.
Product code: Code DTB
Device class: Class 3
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 1996-10-15
Decision date: 1997-04-01
Decision: Substantially Equivalent - Subject to Tracking & PMS
Clearance type: Traditional
Location: Palm Harbor, FL, 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 Oscor Medical Corp.

view all

K925168 — MISCELLANEOUS PACING LEAD1994-05-03
K923621 — EXTERNAL DEMAND PACEMAKER1993-05-19
K912867 — OSCOR MEDICAL CORP PERMANENT PACING LEAD1992-02-04
K915007 — PERMANENT PACING LEADS, MODIFICATION1992-01-27
K915008 — PERMANENT PACING PAD, MODIFICATION1992-01-27

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.