PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE— 510(k) K905548
Substantially EquivalentMallinckrodt Medical
FDA 510(k) clearance K905548 for PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE, Substantially Equivalent on 1991-02-25. Applicant: Mallinckrodt Medical. Device class: 2.
Clearance details
- Applicant
- Mallinckrodt Medical
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St Louis, MO, US
Recent devices under product code DQX
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 DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.