MWS · Stabilizer, Heart
Cardiovascular · 21 CFR 870.4500 · Class 1
Overview
| Product Code | MWS |
|---|---|
| Device Name | Stabilizer, Heart |
| Regulation | 21 CFR 870.4500 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K041338 | MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES | Medtronic Vascular | Jul 19, 2004 | SESE |
| K992476 | PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS | Pilling Weck Surgical | Sep 13, 2000 | SESE |
| K992833 | VACUUM ASSIST STABILIZER | Cardio Thoracic Systems | Nov 10, 1999 | SESE |
| K982419 | HEART-LIFT BALLOON POSITIONER | Cardiothoracic Systems, Inc. | Jan 13, 1999 | SESE |
Top Applicants
- Pilling Weck Surgical — 1 clearance
- Medtronic Vascular — 1 clearance
- Cardiothoracic Systems, Inc. — 1 clearance
- Cardio Thoracic Systems — 1 clearance
