510(k) K982419
- Device
- HEART-LIFT BALLOON POSITIONER
- Applicant
- CARDIOTHORACIC SYSTEMS, INC.
- 510(k) number
- K982419
- Product code
- MWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-01-13
- Date received
- 1998-07-13
- Regulation
- 870.4500
- Classification name
- Stabilizer, Heart
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MIKE BILLIG
- Address
- 10600 N. Tantau Ave. Cupertino CA US 95014 95014
FDA Registration Numbers#
- 3005587147
- 2184009
- 2245304
- 1519227
- 3011137372
- 1646747
- 2011171
- 3006897899
- 1928237
- 3025376090
- 2028523
- 3010041511
- 3002807090
- 3007417753
- 1319639
- 2916714
- 2242352
- 2029275
- 1319660
- 3010141954
- 1000163068
- 3014967969
- 1836324
- 3042172872
- 2027062
- 9616679
- 1118880
- 1720747
- 2015691
- 1723241
- 8010697
- 8040510
- 3006847952
- 3003955307
- 9610612
- 2953359
- 3008595179
- 3007421149
- 1124841
- 3010701807
- 9680721
Source Documents#
Other 510(k) Records For Product Code MWS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041338 | MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES | Medtronic Vascular | 2004-07-19 |
| K992476 | PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS | Pilling Weck Surgical | 2000-09-13 |
| K992833 | VACUUM ASSIST STABILIZER | Cardio Thoracic Systems | 1999-11-10 |
Legacy Summary#
summary
FDA Review#
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