510(k) K962858
K962858 is an FDA 510(k) premarket notification submitted by Heartport, Inc. for the device "HEARTPORT ENDOVASCULAR CARDIOPULMONARY BYPASS SYSTEM ANTEGRADE SYTEM (CATALOG NUMBER ECPB-A) ANTEGRADE/RETROGRADE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 30, 1996. 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
- September 30, 1996
- Date Received
- July 22, 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