NQG · Stabilizer, Heart, Non-Compression, Reprocessed
Cardiovascular · 21 CFR 870.4500 · Class 1
Overview
| Product Code | NQG |
|---|---|
| Device Name | Stabilizer, Heart, Non-Compression, Reprocessed |
| Regulation | 21 CFR 870.4500 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070036 | REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES | Ascent Healthcare Solutions | Aug 17, 2007 | SESE |
| K070034 | REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES | Ascent Healthcare Solutions | Aug 17, 2007 | SESE |
| K063844 | REPROCESSED HEART STABILIZERS AND POSITIONERS | Sterilmed, Inc. | Mar 15, 2007 | SESE |
Top Applicants
- Ascent Healthcare Solutions — 2 clearances
- Sterilmed, Inc. — 1 clearance
