JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
FDA 510(k) clearance K180795 · decided 2018-04-12
Clearance details
- K-number
- K180795
- Device name
- JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2018-03-27
- Decision date
- 2018-04-12
- Days to decision
- 16 days
- Clearance type
- Special
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.