510(k) K992833
K992833 is an FDA 510(k) premarket notification submitted by Cardio Thoracic Systems for the device "VACUUM ASSIST STABILIZER". The FDA issued a decision of Substantially Equivalent on November 10, 1999. The device falls under product code MWS (Stabilizer, Heart), a Class I device regulated under 21 CFR 870.4500. Cardio Thoracic Systems has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 1999
- Date Received
- August 23, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stabilizer, Heart
- Device Class
- Class I
- Regulation Number
- 870.4500
- Review Panel
- CV
- Submission Type