510(k) K170759
K170759 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "CRE Pulmonary Balloon Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on Jun 23, 2017. The device falls under product code KTI (Bronchoscope Accessory), a Class II device regulated under 21 CFR 874.4680. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 23, 2017
- Date Received
- Mar 13, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bronchoscope Accessory
- Device Class
- Class II
- Regulation Number
- 874.4680
- Review Panel
- EN
- Submission Type
- 510(k)
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).