WARMTOUCH PLASTIC WARMING COVER— 510(k) K943276
Substantially EquivalentMallinckrodt Medical
FDA 510(k) clearance K943276 for WARMTOUCH PLASTIC WARMING COVER, Substantially Equivalent on 1994-09-19. Applicant: Mallinckrodt Medical. Device class: 2.
Clearance details
- Applicant
- Mallinckrodt Medical
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St Louis, MO, US
Recent devices under product code DWJ
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view all- K082520 — SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
- K051416 — SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA
- K972258 — HI-CARE CLOSED SUCTION SYSTEM
- K971267 — SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
- K963732 — PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
Adverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
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.