# K964488: Detachable Silicone Balloon (DSB)

- Pathway: 510(k) (Traditional)
- Applicant: Target Therapeutics
- Decided: Apr 21, 1998 after 529 days
- Product code: MZQ (Balloon, Detachable, For Neurovascular Occlusion)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951256 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960705: Guglielmi Detachable Coil, Target Therapeutics (1996) Summary page 3.
- K871047: Radiopaque Spherical Emboli (Rse), Interventional Therapeutics Corp. (1987) Summary page 3.
- K944354: Contour Emboli, Interventional Therapeutics Corp. (1994) Summary page 3.
- (no number) Target Therapeutics (ITC) Occlusion Balloon Catheter: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K964488
Methodology: https://510kreport.com/methodology