510(k) K051655
K051655 is an FDA 510(k) premarket notification submitted by AngioDynamics, Inc. for the device "ANGIODYNAMICS, INC., MICRO ACCESS KITS". The FDA issued a decision of Substantially Equivalent on September 12, 2005. The device falls under product code DQR (Cannula, Catheter), a Class II device regulated under 21 CFR 870.1300. AngioDynamics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2005
- Date Received
- June 21, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1300
- Review Panel
- CV
- Submission Type