510(k) K982419
K982419 is an FDA 510(k) premarket notification submitted by Cardiothoracic Systems, Inc. for the device "HEART-LIFT BALLOON POSITIONER". The FDA issued a decision of Substantially Equivalent on January 13, 1999. The device falls under product code MWS (Stabilizer, Heart), a Class I device regulated under 21 CFR 870.4500. Cardiothoracic Systems, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 1999
- Date Received
- July 13, 1998
- 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