510(k) K170258
K170258 is an FDA 510(k) premarket notification submitted by AngioDynamics, Inc. for the device "SpeedLyser Infusion Catheter Kit". The FDA issued a decision of Substantially Equivalent on Feb 21, 2017. The device falls under product code QEY (Mechanical Thrombolysis Catheter), a Class II device regulated under 21 CFR 870.5150. AngioDynamics, Inc. has 89 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 21, 2017
- Date Received
- Jan 27, 2017
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mechanical Thrombolysis Catheter
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type
- 510(k)
To mechanically disrupt thrombus and/or debris in the peripheral vasculature.