510(k) K161986
K161986 is an FDA 510(k) premarket notification submitted by Bard Peripheral Vascular, Inc. for the device "SIDEKICK and USHER Support Catheters". The FDA issued a decision of Substantially Equivalent on August 4, 2016. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Bard Peripheral Vascular, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 2016
- Date Received
- July 19, 2016
- Clearance Type
- Special
- 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