Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
FDA 510(k) clearance K193576 · decided 2020-11-20
Clearance details
- K-number
- K193576
- Device name
- Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Decision
- Substantially Equivalent
- Date received
- 2019-12-23
- Decision date
- 2020-11-20
- Days to decision
- 333 days
- Clearance type
- Traditional
- Product code
- POL
- Device class
- 2
- Regulation number
- 882.5600
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.