CRE Pulmonary Balloon Dilatation Catheter
FDA 510(k) clearance K170759 · decided 2017-06-23
Clearance details
- K-number
- K170759
- Device name
- CRE Pulmonary Balloon Dilatation Catheter
- Applicant
- Boston Scientific Corporation
- Decision
- Substantially Equivalent
- Date received
- 2017-03-13
- Decision date
- 2017-06-23
- Days to decision
- 102 days
- Clearance type
- Special
- Product code
- KTI
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Marlboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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