510(k) K182937
K182937 is an FDA 510(k) premarket notification submitted by Upstream Peripheral Technologies, Ltd. for the device "Upstream GoBack Crossing Catheter". The FDA issued a decision of Substantially Equivalent on May 23, 2019. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Upstream Peripheral Technologies, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2019
- Date Received
- October 22, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type