MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter— 510(k) K161779
Substantially EquivalentMedsource International, LLC
FDA 510(k) clearance K161779 for MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Catheter, Substantially Equivalent on 2016-11-03. 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
- Chaska, 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
- 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
- K131555 — MEDSOURCE IV SAFETY CATHETER
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.