510(k) K965051
K965051 is an FDA 510(k) premarket notification submitted by Heartport, Inc. for the device "HEARTPORT NEEDLE TROCAR". The FDA issued a decision of Substantially Equivalent on March 12, 1997. The device falls under product code DRC (Trocar), a Class II device regulated under 21 CFR 870.1390. Heartport, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1997
- Date Received
- December 18, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trocar
- Device Class
- Class II
- Regulation Number
- 870.1390
- Review Panel
- CV
- Submission Type