ArchFlo CT Midline— 510(k) K171483
Substantially EquivalentMedcomp (Dba Medical Components, Inc.)
FDA 510(k) clearance K171483 for ArchFlo CT Midline, Substantially Equivalent on 2017-12-15. Applicant: Medcomp (Dba Medical Components, Inc.).
Clearance details
- Applicant
- Medcomp (Dba Medical Components, Inc.)
- Product code
- Code PND
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Harleysville, PA, US
Adverse events under product code PND
product code PND- Injury
- 149
- Malfunction
- 695
- Other
- 1
- Total
- 845
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.