EXTERNAL DEMAND PACEMAKER— 510(k) K923621

Name: FDA 510(k) clearance K923621
Creator: U.S. Food and Drug Administration
Published: 1993-05-19

Substantially Equivalent

Oscor Medical Corp.

FDA 510(k) clearance K923621 for EXTERNAL DEMAND PACEMAKER, Substantially Equivalent on 1993-05-19. Applicant: Oscor Medical Corp.. Device class: 2.

Clearance details

Applicant: Oscor Medical Corp.
Product code: Code DTE
Device class: Class 2
Regulation: 21 CFR 870.3600
Advisory panel: Cardiovascular
Date received: 1992-07-21
Decision date: 1993-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harbor, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTE

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K232721 — Lifetech Cardio Temporary Pacemaker2024-01-07
K201011 — Medtronic Model 5392 External Pulse Generator (EPG)2020-05-13
K190825 — Medtronic Model 5392 External Pulse Generator (EPG)2019-04-30
K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker2019-02-28

More clearances from Oscor Medical Corp.

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K964107 — OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR1997-04-01
K925168 — MISCELLANEOUS PACING LEAD1994-05-03
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 DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

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.