Product code MWS
- Device name
- Stabilizer, Heart
- Medical specialty
- Cardiovascular
- Device class
- 1
- Regulation number
- 870.4500
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K982419 | HEART-LIFT BALLOON POSITIONER | Cardiothoracic Systems, Inc. | 1999-01-13 |
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| 04545499071699 | Tentacles NEO | SB-KAWASUMI LABORATORIES, INC. | 2019-11-15 |
| 00192896070295 | HEART STABILIZER FINGER ATTACHMENT | SONTEC INSTRUMENTS, INC. | 2018-09-07 |
| 00192896070318 | HEART STABILIZER FINGER ATTACHMENT | SONTEC INSTRUMENTS, INC. | 2018-09-07 |
| 00192896070233 | HEARTLINE STABILIZER ARM | SONTEC INSTRUMENTS, INC. | 2018-09-07 |
| 00192896070240 | STABILIZER TIPS | SONTEC INSTRUMENTS, INC. | 2018-09-07 |
| 00192896070257 | STABILIZER TIPS | SONTEC INSTRUMENTS, INC. | 2018-09-07 |
| 00192896070301 | HEART STABILIZER FINGER ATTACHMENT | SONTEC INSTRUMENTS, INC. | 2018-09-07 |
| 00899054002548 | Viper II Apical Lift | KDL MEDICAL, INC. | 2018-04-20 |
| 00899054002487 | Viper I Heart Stabilizer | KDL MEDICAL, INC. | 2017-08-24 |
| 00899054002494 | Viper II Heart Stabilizer | KDL MEDICAL, INC. | 2017-08-24 |
| 00899054002500 | Viper II Heart Stabilizer | KDL MEDICAL, INC. | 2017-08-24 |
| 00899054002517 | TRIPOD Heart Stabilizer Nylon Occ FsTrac | KDL MEDICAL, INC. | 2017-08-24 |
| 00899054002524 | TRIPOD Heart Stabilizer Lt Metal w/Occ | KDL MEDICAL, INC. | 2017-08-24 |
| 00899054002531 | TRIPOD Heart Stabilizer Nylon Blwr/Occ | KDL MEDICAL, INC. | 2017-08-24 |
| 00899054002432 | TRIPOD Heart Stabilizer Med Mtl FasTract | KDL MEDICAL, INC. | 2017-08-24 |
| 00899054002463 | TRIPOD Heart Stabilizer- Lt Mtl Fastract | KDL MEDICAL, INC. | 2017-08-23 |
| 00899054002470 | TRIPOD Stabilizer- Lt Mtl Fastract +2cm | KDL MEDICAL, INC. | 2017-08-23 |
| 00899054002456 | TRIPOD Stabilizer-Nylon Fastract +2cm | KDL MEDICAL, INC. | 2017-08-23 |
| 00899054002449 | TRIPOD Heart Stabilizer-Nylon Fastract | KDL MEDICAL, INC. | 2017-08-23 |
| 00899054002265 | Viper II Apical Lift | KDL MEDICAL, INC. | 2017-08-23 |