510(k) K011078
K011078 is an FDA 510(k) premarket notification submitted by Allegiance Healthcare Corp. for the device "MALLEABLE SHAFT CLAMP". The FDA issued a decision of Substantially Equivalent on July 13, 2001. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Allegiance Healthcare Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 13, 2001
- Date Received
- April 9, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type