PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)— 510(k) K963098
Substantially EquivalentDeknatel, Inc.
FDA 510(k) clearance K963098 for PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100), Substantially Equivalent on 1996-11-08. Applicant: Deknatel, Inc.. Device class: 2.
Clearance details
- Applicant
- Deknatel, Inc.
- Product code
- Code CAC
- Device class
- Class 2
- Regulation
- 21 CFR 868.5830
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fall River, MA, US
Recent devices under product code CAC
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Adverse events under product code CAC
product code CAC- Death
- 11
- Malfunction
- 477
- Total
- 488
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.