Stabilizer, Heart, Non-Compression, Reprocessed
The non-compression heart stabilizer (reprocessed) is a cardiovascular surgical device used to stabilize, move, lift, and position the heart during off-pump or minimally invasive cardiovascular surgery. It is classified as FDA Class 1 under regulation 870.4500 in the Cardiovascular specialty, subject to general controls but not GMP exempt, and requires a 510(k) submission including reprocessing validation data. Product code NQG is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NQG
- Device Class
- FDA class 1
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
The device is used to stabilize, move, lift, and position the heart during cardiovascular surgery. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070036 | REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING DEVICES | Aug 17, 2007 | Substantially Equivalent | Ascent Healthcare Solutions |
| K070034 | REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES | Aug 17, 2007 | Substantially Equivalent | Ascent Healthcare Solutions |
| K063844 | REPROCESSED HEART STABILIZERS AND POSITIONERS | Mar 15, 2007 | Substantially Equivalent | Sterilmed, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.