DYNAREX SUCTION CATHETERS & KITS— 510(k) K922843
Substantially EquivalentDynarex Corp.
FDA 510(k) clearance K922843 for DYNAREX SUCTION CATHETERS & KITS, Substantially Equivalent on 1993-01-11. Applicant: Dynarex Corp.. Device class: 1.
Clearance details
- Applicant
- Dynarex Corp.
- Product code
- Code BSY
- Device class
- Class 1
- Regulation
- 21 CFR 868.6810
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brewster, NY, US
Recent devices under product code BSY
view allMore clearances from Dynarex Corp.
view all- K052743 — DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921
- K052314 — DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM, 4913-LARGE
- K012816 — DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
- K012957 — TOWEL DRAPE, MODELS 4409, 4410
- K012917 — DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
Adverse events under product code BSY
product code BSY- Death
- 3
- Injury
- 155
- Malfunction
- 959
- Total
- 1,117
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.