510(k) K170636
K170636 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Fathom-16 Steerable Guidewires". The FDA issued a decision of Substantially Equivalent on Mar 22, 2017. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Boston Scientific Corporation has 238 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 22, 2017
- Date Received
- Mar 2, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wire, Guide, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1330
- Review Panel
- CV
- Submission Type
- 510(k)