Sentrant Introducer Sheath with Hydrophilic Coating
FDA 510(k) clearance K171866 · decided 2017-12-20
Clearance details
- K-number
- K171866
- Device name
- Sentrant Introducer Sheath with Hydrophilic Coating
- Applicant
- Medtronic Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-06-22
- Decision date
- 2017-12-20
- Days to decision
- 181 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Rosa, 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.
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| VenaSeal Closure System (P140018/S046) | Medtronic Vascular, Inc. | 2025-09-23 |