PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR— 510(k) K962856
Substantially EquivalentDeknatel, Inc.
FDA 510(k) clearance K962856 for PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR, Substantially Equivalent on 1996-08-28. 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
- Fall River, MA, US
Recent devices under product code KDQ
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- K964070 — DEKNATEL DSP PLEUR-EVAC AUTOTRANSFUSION BLOOD RECOVERY BAG
- 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 →
Recalls naming K962856
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962856.
Data sourced from openFDA. This site is unofficial and independent of the FDA.