Detachable Slicone Balloon (DSB)

FDA 510(k) K965071 · Target Therapeutics

Substantially Equivalent

510(k) numberK965071

Submission

Device name
Detachable Slicone Balloon (DSB)
Applicant
Target Therapeutics
Freemont, CA, US
Received
December 19, 1996
Decision date
April 21, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MZQ – Balloon, Detachable, For Neurovascular Occlusion
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5950
Specialty
Neurology
Implant
Yes
Life-sustaining
Yes

Other 510(k)s with product code MZQ

510(k)DeviceApplicantDecision
K964488Detachable Silicone Balloon (DSB)MZQ · Traditional Target Therapeutics04/21/1998SE

More from Target Therapeutics

510(k)DeviceDecision
K964488Detachable Silicone Balloon (DSB)MZQ · Traditional 04/21/1998SE
K964210Retriever IIDQO · Traditional 10/31/1997SE
K971395Guglielmi Detachable Coil (GDC), Fibered Platinum Coil, .035 Type, Berenstein Liquid…DQX · Traditional 07/14/1997SE
K965189SpinnakerKRA · Traditional 03/24/1997SE
K964112Berenstein CoilKRD · Traditional 02/26/1997SE
K963307GDC Patient Return Electtrode Model 45021HCG · Traditional 12/17/1996SE
K962503Guglielmi Detachable CoilHCG · Traditional 09/20/1996SE
K961923Berenstein CoilHCG · Traditional 08/15/1996SE
K960705Guglielmi Detachable CoilHCG · Traditional 05/21/1996SE
K960806Turbo TrackerDQO · Traditional 05/02/1996SE

Questions and answers

When was Detachable Slicone Balloon (DSB) cleared by the FDA?

Detachable Slicone Balloon (DSB) (K965071) received a 510(k) decision of Substantially Equivalent on April 21, 1998, 488 days after the submission was received.

What is the product code of K965071?

The FDA product code is MZQ – Balloon, Detachable, For Neurovascular Occlusion, a Class II (moderate risk) device regulated under 21 CFR 882.5950.