Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)— 510(k) K242705

Name: FDA 510(k) clearance K242705
Creator: U.S. Food and Drug Administration
Published: 2025-01-17

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K242705 for Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500), Substantially Equivalent on 2025-01-17. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code LDF
Device class: Class 2
Regulation: 21 CFR 870.3680
Advisory panel: Cardiovascular
Date received: 2024-09-09
Decision date: 2025-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Miinneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

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.