Unimpregnated Central Venous Catheter— 510(k) K260165
Substantially EquivalentSpectrum Vascular
FDA 510(k) clearance K260165 for Unimpregnated Central Venous Catheter, Substantially Equivalent on 2026-08-10. Applicant: Spectrum Vascular. Device class: 2.
Clearance details
- Applicant
- Spectrum Vascular
- 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
- White Plains, NY, US
Recent devices under product code FOZ
view allMore clearances from Spectrum Vascular
view all- K261455 — Arterial Pressure Monitoring Set/Tray
- K254278 — Arterial Pressure Monitoring Set/Tray
- K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more
- K250724 — Intraosseous Infusion Needles
- K241115 — SV Spectrum MRC Central Venous Catheter; SV Spectrum MR Central Venous Catheter; SV Central Venous 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.