FieldFlex Steerable Sheath
FDA 510(k) clearance K261492 · decided 2026-06-05
Clearance details
- K-number
- K261492
- Device name
- FieldFlex Steerable Sheath
- Applicant
- CenterPoint Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2026-05-06
- Decision date
- 2026-06-05
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- West Valley City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.