GUEDEL AIRWAY— 510(k) K953400
Substantially EquivalentMallinckrodt Medical
FDA 510(k) clearance K953400 for GUEDEL AIRWAY, Substantially Equivalent on 1995-10-24. Applicant: Mallinckrodt Medical. Device class: 1.
Clearance details
- Applicant
- Mallinckrodt Medical
- Product code
- Code CAE
- Device class
- Class 1
- Regulation
- 21 CFR 868.5110
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St Louis, MO, US
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- K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA)
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- 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 CAE
product code CAE- Death
- 4
- Total
- 4
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.