MOBICATH TRANSSEPTAL NEEDLE— 510(k) K111644

Name: FDA 510(k) clearance K111644
Creator: U.S. Food and Drug Administration
Published: 2011-10-03

Substantially Equivalent

Great Batch Medical

FDA 510(k) clearance K111644 for MOBICATH TRANSSEPTAL NEEDLE, Substantially Equivalent on 2011-10-03. Applicant: Great Batch Medical. Device class: 2.

Clearance details

Applicant: Great Batch Medical
Product code: Code DRC
Device class: Class 2
Regulation: 21 CFR 870.1390
Advisory panel: Cardiovascular
Date received: 2011-06-13
Decision date: 2011-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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K210328 — SafeSept Blunt Needle2021-03-05

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K122832 — MOBICATH TRANSSEPTAL NEEDLE2012-12-19
K112541 — Z FLEX-270TM STEERABLE SHEATH2012-02-07
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Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.