TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934— 510(k) K052413
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K052413 for TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934, Substantially Equivalent on 2005-11-17. Applicant: Medtronic Vascular. Device class: 2.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code KNS
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shoreview, MN, US
Recent devices under product code KNS
view allMore clearances from Medtronic Vascular
view all- K232570 — Steerant Super Stiff Guidewire
- K232190 — 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
- K230156 — 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
- K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200) +3 more
- K192296 — Medtronic 6F Taiga Guiding Catheter
Adverse events under product code KNS
product code KNS- Death
- 44
- Injury
- 2,361
- Malfunction
- 4,771
- Total
- 7,176
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.