15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes— 510(k) K173667

Unknown

Medical Components, Inc. (dba MedComp)

FDA 510(k) clearance K173667 for 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, Unknown on 2018-05-17. Applicant: Medical Components, Inc. (dba MedComp).

Clearance details

Applicant
Medical Components, Inc. (dba MedComp)
Product code
Code MSD
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
Harleysville, PA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MSD

product code MSD
Death
67
Injury
545
Malfunction
3,661
Total
4,273

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.