VS3-IR— 510(k) K183453
Substantially EquivalentMedtronic
FDA 510(k) clearance K183453 for VS3-IR, Substantially Equivalent on 2019-03-04. Applicant: Medtronic. Device class: 2.
Clearance details
- Applicant
- Medtronic
- Product code
- Code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Petach Tikva, Hamerkaz, IL
Recent devices under product code OWN
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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 OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
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.