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.
Summary
Spectrum Vascular's Unimpregnated Central Venous Catheter is filed under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days). The record gives no sizes or model numbers.
Class II, 21 CFR 880.5200. General Hospital is both the classification panel and the review panel. It was a Traditional 510(k).
Spectrum Vascular filed from White Plains, New York. The decision came 202 calendar days after receipt (January 20 to August 10, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Spectrum Vascular
- Product code
- Product 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.