iSLEEVE Introducer Set
FDA 510(k) clearance K190184 · decided 2019-03-07
Clearance details
- K-number
- K190184
- Device name
- iSLEEVE Introducer Set
- Applicant
- Boston Scientific
- Decision
- Substantially Equivalent
- Date received
- 2019-02-01
- Decision date
- 2019-03-07
- Days to decision
- 34 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- 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
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.