510(k) K770802
K770802 is an FDA 510(k) premarket notification submitted by Cardio-Surgical, Inc. for the device "MARKERS, STAINLESS STEEL". The FDA issued a decision of Substantially Equivalent on June 27, 1977. The device falls under product code KPK (Marker, Ostia, Aorto-Saphenous Vein), a Class II device regulated under 21 CFR 878.4650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 1977
- Date Received
- April 26, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Ostia, Aorto-Saphenous Vein
- Device Class
- Class II
- Regulation Number
- 878.4650
- Review Panel
- CV
- Submission Type