STERIVENT AND STERIVENT S— 510(k) K941676
Substantially EquivalentMallinckrodt Medical
FDA 510(k) clearance K941676 for STERIVENT AND STERIVENT S, Substantially Equivalent on 1994-05-20. Applicant: Mallinckrodt Medical. Device class: 2.
Clearance details
- Applicant
- Mallinckrodt Medical
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Argyle, NY, US
Recent devices under product code CAH
view allMore clearances from Mallinckrodt Medical
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 CAH
product code CAH- Death
- 7
- Total
- 7
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 K941676
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 K941676.
Data sourced from openFDA. This site is unofficial and independent of the FDA.