MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE— 510(k) K132623
Substantially EquivalentMedtronic
FDA 510(k) clearance K132623 for MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE, Substantially Equivalent on 2013-12-19. Applicant: Medtronic. Device class: 2.
Clearance details
- Applicant
- Medtronic
- 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
- Santa Rosa, CA, US
Recent devices under product code DQX
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view all- K253530 — Trexon Monofilament Synthetic Absorbable Suture
- K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter
- K233433 — Sphere-9Dx Diagnostic Catheter (AFR-00009)
- K240190 — MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated
- K223494 — CD Horizon Spinal System
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.