510(k) K011003
K011003 is an FDA 510(k) premarket notification submitted by Diasol, Inc. for the device "SAFESTING AND SAFESTING HUB". The FDA issued a decision of Substantially Equivalent on April 20, 2001. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Diasol, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2001
- Date Received
- April 4, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type