(SPAG) MODEL SPAG-2 6000 SERIES— 510(k) K871427
UnknownViratek, Inc.
FDA 510(k) clearance K871427 for (SPAG) MODEL SPAG-2 6000 SERIES, Unknown on 1987-10-06. Applicant: Viratek, Inc.. Device class: 2.
Clearance details
- Applicant
- Viratek, Inc.
- Product code
- Code CAF
- Device class
- Class 2
- Regulation
- 21 CFR 868.5630
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Costa Mesa, CA, US
Recent devices under product code CAF
view allMore clearances from Viratek, Inc.
view allAdverse events under product code CAF
product code CAF- Death
- 22
- Injury
- 125
- Malfunction
- 613
- Other
- 11
- Total
- 771
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 →
Recalls naming K871427
K-number listed on FDA's recall record- Z-0384-2018 — Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air or blended oxygen) and uses a nebulizer to generate a fine aerosol of hydrated Virazole. --- CDRH Classification Name: Nebulizer (Direct Patient Interface)
- Z-0674-2016 — Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.
- Z-0371-2016 — Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K871427.
Data sourced from openFDA. This site is unofficial and independent of the FDA.