Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes— 510(k) K202176
Substantially EquivalentMedical Components, Inc. (dba MedComp)
FDA 510(k) clearance K202176 for Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes, Substantially Equivalent on 2020-09-03. Applicant: Medical Components, Inc. (dba MedComp). Device class: 2.
Clearance details
- Applicant
- Medical Components, Inc. (dba MedComp)
- Product code
- Code MSD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Harleysville, PA, US
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- K173667 — 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
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.