# K122576: Transform Occlusion Balloon Catheter (Compliant and Super Compliant

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Neurovascular
- Decided: Jan 11, 2013 after 141 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K011526 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101570: Hyperglide and Hyperform Occlusion Balloon Systems, Micro Therapeutics Dba Ev3 Neurovascular (2010)

## Recalls of this device
- Nov 4, 2013 · Class II · Z-0505-2014: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
- Nov 4, 2013 · Class II · Z-0507-2014: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
- Nov 4, 2013 · Class II · Z-0512-2014: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
- Nov 4, 2013 · Class II · Z-0508-2014: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
- Nov 4, 2013 · Class II · Z-0509-2014: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
- Nov 4, 2013 · Class II · Z-0510-2014: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
- Nov 4, 2013 · Class II · Z-0511-2014: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
- Nov 4, 2013 · Class II · Z-0506-2014: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.

## Indications for use
The Stryker NeurovascularTransForm Occlusion Balloon Catheters are indicated for use in the neuro and peripheral vasculature to temporarily stop or control blood flow and for balloon assisted embolization of intracranial aneurysms.

Source page: https://510kreport.com/device/K122576
Methodology: https://510kreport.com/methodology