510(k) · Cleared
ClearedReprocessed Guidant Cardiac Stabilization and Positioning Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ascent Healthcare Solutions · NQG Stabilizer, Heart, Non-Compression, Reprocessed
Cleared on Aug 17, 2007 as substantially equivalent to K992833 (Cardio Thoracic Systems, 1999) and 1 other predicate after a 226-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Aug 17, 2007
- Review
- 226 days
- Class
- Class I
- Product code
- NQG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964445 (1997). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK964445 Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)Dlp, Inc. · 1997
- 1 generation backK992833 Vacuum Assist StabilizerCardio Thoracic Systems · 1999
- This deviceK070034 Reprocessed Guidant Cardiac Stabilization and Positioning DevicesAscent Healthcare Solutions · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964445 | Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006) | Dlp, Inc. | 1997 | — |
| −1 | K992833 | Vacuum Assist Stabilizer | Cardio Thoracic Systems | 1999 | — |
| 0 (this device) | K070034 | Reprocessed Guidant Cardiac Stabilization and Positioning Devices | Ascent Healthcare Solutions | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NQG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992833 | Vacuum Assist StabilizerSummary page 1…Positioning Devices Classification Name: Cardiovascular surgical instruments Predicate Device 510(k) Title Manufacturer K992833 Vacuum Assist Stabilizer CardioThoracic Systems (Guidant) K982419 CTS Heart-Lift Balloon… | 1999 |
| * | K982419 | Heart-Lift Balloon PositionerSummary page 1…al instruments Predicate Device 510(k) Title Manufacturer K992833 Vacuum Assist Stabilizer CardioThoracic Systems (Guidant) K982419 CTS Heart-Lift Balloon CardioThoracic Systems (Guidant) Positioner Note: These are c… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K992833.
How does its category compare?
All NQG devicesNQG Stabilizer, Heart, Non-Compression, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NQG
3in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · NQG
226in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQG
No recall names NQG since 2007.
Adverse event reports per year · NQG
2in 2018
MAUDE reports naming product code NQG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 226 | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070034 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070034: Reprocessed Guidant Cardiac Stabilization and Positioning Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070034
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026