510(k) · Cleared
ClearedDetachable Silicone Balloon (DSB)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Target Therapeutics · MZQ Balloon, Detachable, For Neurovascular Occlusion
Cleared on Apr 21, 1998 as substantially equivalent to K960705 (Target Therapeutics, 1996) and 2 other predicates after a 529-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Apr 21, 1998
- Review
- 529 days
- Class
- Class II
- Product code
- MZQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K951256 (1995). 4 ancestors in all, the oldest K871047 (1987). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951256 | Detachable Platinum Coil (Guglielmi Detachable Coil, GDC) | Target Therapeutics | 1995 | — |
| −1 | K960705 | Guglielmi Detachable Coil | Target Therapeutics | 1996 | — |
| 0 (this device) | K964488 | Detachable Silicone Balloon (DSB) | Target Therapeutics | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 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 MZQ? 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? (4)
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 |
|---|---|---|---|
| * | K960705 | Guglielmi Detachable CoilSummary page 3…evice function Material Delivery method Deployment method Proposed Predicate Detachable Silicone Target Therapeutics Balloon (DSB) Detachable Platinum Coil (GDC) K960705 Predicate Target Therapeutics (ITC) Radiopaque Spherical Emboli (RSE) K871047 Predicate Target Therapeutics (ITC) Contour Em… | 1996 |
| * | K871047 | Radiopaque Spherical Emboli (Rse)Summary page 3…Detachable Silicone Target Therapeutics Balloon (DSB) Detachable Platinum Coil (GDC) K960705 Predicate Target Therapeutics (ITC) Radiopaque Spherical Emboli (RSE) K871047 Predicate Target Therapeutics (ITC) Contour Emboli (CE) K944354 Artificial embolization device Occlusion of carotid cavernous… | 1987 |
| * | K944354 | Contour EmboliSummary page 3…le Platinum Coil (GDC) K960705 Predicate Target Therapeutics (ITC) Radiopaque Spherical Emboli (RSE) K871047 Predicate Target Therapeutics (ITC) Contour Emboli (CE) K944354 Artificial embolization device Occlusion of carotid cavernous fistulae Creates a physical barrier to effect vascular occlusion… | 1994 |
| * | — | Target Therapeutics (ITC) Occlusion Balloon Catheter Named without a submission number |
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 3 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
- 6 other devices also cite its predicate K960705.
How does its category compare?
All MZQ devicesMZQ Balloon, Detachable, For Neurovascular Occlusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MZQ
FDA has decided no MZQ device since 2007.
Median 510(k) review, days · MZQ
Too few MZQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MZQ
No recall names MZQ since 2007.
Adverse event reports per year · MZQ
1in 2011
MAUDE reports naming product code MZQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 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 | 0 |
| 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?
The DSB is intended for artificial embolization of symptomatic carotid cavernous fistulae in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964488 · printed Nov 3, 2026
Cite this page
510(k) Report. “K964488: Detachable Silicone Balloon (DSB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K964488
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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