SAFELINE I.V. BAG ACCESS DEVICE— 510(k) K955594

Name: FDA 510(k) clearance K955594
Creator: U.S. Food and Drug Administration
Published: 1996-03-06

Substantially Equivalent

Mcgaw, Inc.

FDA 510(k) clearance K955594 for SAFELINE I.V. BAG ACCESS DEVICE, Substantially Equivalent on 1996-03-06. Applicant: Mcgaw, Inc.. Device class: 2.

Clearance details

Applicant: Mcgaw, Inc.
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1995-12-08
Decision date: 1996-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K941244 — SAFELINE SYSTEM TURN LOCK CANNULA1994-11-29
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Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.