PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE— 510(k) K881252
Substantially EquivalentDeknatel, Inc.
FDA 510(k) clearance K881252 for PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE, Substantially Equivalent on 1988-06-17. Applicant: Deknatel, Inc.. Device class: 2.
Clearance details
- Applicant
- Deknatel, Inc.
- 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
- Lake Success, NY, US
Recent devices under product code GCX
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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.