510(k) K964161
K964161 is an FDA 510(k) premarket notification submitted by Heartport, Inc. for the device "HEARTPORT ENDOAORTIC CLAMP". The FDA issued a decision of Substantially Equivalent on April 4, 1997. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Heartport, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 4, 1997
- Date Received
- October 17, 1996
- Clearance Type
- Traditional
- 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