MEDSOURCE IV SAFETY CATHETER— 510(k) K131555
Substantially EquivalentMedsource International, LLC
FDA 510(k) clearance K131555 for MEDSOURCE IV SAFETY CATHETER, Substantially Equivalent on 2014-01-31. Applicant: Medsource International, LLC. Device class: 2.
Clearance details
- Applicant
- Medsource International, LLC
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mound, MN, US
Recent devices under product code FOZ
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 FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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.