MEDSOURCE IV ADMINSTRATION SET— 510(k) K120424
Substantially EquivalentMedsource International, LLC
FDA 510(k) clearance K120424 for MEDSOURCE IV ADMINSTRATION SET, Substantially Equivalent on 2012-07-11. Applicant: Medsource International, LLC. Device class: 2.
Clearance details
- Applicant
- Medsource International, LLC
- Product code
- Code LHI
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mound, MN, US
Recent devices under product code LHI
view allMore clearances from Medsource International, LLC
view all- K223788 — The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter
- K161779 — MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter
- K150333 — MedSource Sharps Dart
- K140442 — MEDSOURCE SELECTABLE IV SET
- K140402 — MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET
Adverse events under product code LHI
product code LHI- Injury
- 207
- Malfunction
- 7,820
- Other
- 3
- Total
- 8,030
Source: openFDA MAUDE database, through . 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.