510(k) K080169
K080169 is an FDA 510(k) premarket notification submitted by Guidant Corporation, Cardiac Surgery for the device "HEARTSTRING III PROXIMAL SEAL SYSTEM". The FDA issued a decision of Substantially Equivalent on February 8, 2008. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Guidant Corporation, Cardiac Surgery has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2008
- Date Received
- January 24, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type