MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
FDA 510(k) clearance K211344 · decided 2021-05-28
Clearance details
- K-number
- K211344
- Device name
- MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems
- Applicant
- Medos International SARL
- Decision
- Substantially Equivalent
- Date received
- 2021-05-03
- Decision date
- 2021-05-28
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Le Locle, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.