510(k) K190126
K190126 is an FDA 510(k) premarket notification submitted by Bend IT Technologies, Ltd. for the device "Bendit2.7 Steerable Microcatheter". The FDA issued a decision of Substantially Equivalent on August 22, 2019. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Bend IT Technologies, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2019
- Date Received
- January 28, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type