MEDI-VAC FLEXI-CLEAR SUCTION HANDLE— 510(k) K964127
Substantially EquivalentAllegiance Healthcare Corp.
FDA 510(k) clearance K964127 for MEDI-VAC FLEXI-CLEAR SUCTION HANDLE, Substantially Equivalent on 1996-12-31. Applicant: Allegiance Healthcare Corp.. Device class: 2.
Clearance details
- Applicant
- Allegiance Healthcare Corp.
- Product code
- Code GCX
- Device class
- Class 2
- Regulation
- 21 CFR 880.6740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcgraw Park, IL, US
Recent devices under product code GCX
view allMore clearances from Allegiance Healthcare Corp.
view all- K023673 — AIRLIFE DEMAND NASAL CANNULA
- K023419 — TRILAMINATE DRAPES/TIBURON
- K024120 — MODIFICATION TO TEMNO BIOPSY NEEDLES
- K024292 — MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
- K024102 — DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
Adverse events under product code GCX
product code GCX- Death
- 9
- Malfunction
- 592
- Other
- 2
- Total
- 603
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.