HEART-LIFT BALLOON POSITIONER
FDA 510(k) clearance K982419 · decided 1999-01-13
Clearance details
- K-number
- K982419
- Device name
- HEART-LIFT BALLOON POSITIONER
- Applicant
- Cardiothoracic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-13
- Decision date
- 1999-01-13
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- MWS
- Device class
- 1
- Regulation number
- 870.4500
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Cupertino, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES (K041338) | Medtronic Vascular | 2004-07-19 |
| PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS (K992476) | Pilling Weck Surgical | 2000-09-13 |
| VACUUM ASSIST STABILIZER (K992833) | Cardio Thoracic Systems | 1999-11-10 |
Recalls involving this device
No recalls on record reference this clearance.