510(k) K200634
K200634 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. for the device "Arrow FiberOptix Intra-Aortic Balloon Catheter Kit". The FDA issued a decision of Substantially Equivalent on April 9, 2020. The device falls under product code DSP (System, Balloon, Intra-Aortic And Control), a Class II device regulated under 21 CFR 870.3535. Arrow International, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2020
- Date Received
- March 10, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Balloon, Intra-Aortic And Control
- Device Class
- Class II
- Regulation Number
- 870.3535
- Review Panel
- CV
- Submission Type