CT Midline— 510(k) K170770

Name: FDA 510(k) clearance K170770
Creator: U.S. Food and Drug Administration
Published: 2017-07-25

Substantially Equivalent

Medical Components, Inc. (dba MedComp)

FDA 510(k) clearance K170770 for CT Midline, Substantially Equivalent on 2017-07-25. Applicant: Medical Components, Inc. (dba MedComp). Device class: 2.

Clearance details

Applicant: Medical Components, Inc. (dba MedComp)
Product code: Code PND
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2017-03-14
Decision date: 2017-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Medical Components, Inc. (dba MedComp)

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K192807 — Duo-Flow Side x Side Double Lumen Catheter2020-04-23
K183219 — Trio-CT Triple Lumen Catheter2019-06-14
K181175 — 12F Tri-Flow Triple Lumen Catheter2018-07-05

Adverse events under product code PND

product code PND

Injury: 149
Malfunction: 695
Other: 1
Total: 845

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.