PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION— 510(k) K892915
Substantially EquivalentDeknatel, Inc.
FDA 510(k) clearance K892915 for PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION, Substantially Equivalent on 1989-06-21. Applicant: Deknatel, Inc.. Device class: 2.
Clearance details
- Applicant
- Deknatel, Inc.
- Product code
- Code KDQ
- Device class
- Class 2
- Regulation
- 21 CFR 880.6740
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose-Heredia, CR
Recent devices under product code KDQ
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- K963098 — PLEUR-EVAC SHARA PLUS MODEL S-2150/CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM(S-100)
- K925243 — DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER
Adverse events under product code KDQ
product code KDQ- Death
- 8
- Malfunction
- 637
- Total
- 645
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.