MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES— 510(k) K041338
Substantially EquivalentMedtronic Vascular
FDA 510(k) clearance K041338 for MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES, Substantially Equivalent on 2004-07-19. Applicant: Medtronic Vascular. Device class: 1.
Clearance details
- Applicant
- Medtronic Vascular
- Product code
- Code MWS
- Device class
- Class 1
- Regulation
- 21 CFR 870.4500
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brooklyn Park, MN, US
Recent devices under product code MWS
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 MWS
product code MWS- Death
- 4
- Total
- 4
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.