Cleared Traditional

DETACHABLE SLICONE BALLOON (DSB) (K965071) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K965071 · Target Therapeutics · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
488d
Days
Class 2
Risk

K965071 is an FDA 510(k) clearance for the DETACHABLE SLICONE BALLOON (DSB). Classified as Balloon, Detachable, For Neurovascular Occlusion (product code MZQ), Class II - Special Controls.

Submitted by Target Therapeutics (Freemont, US). The FDA issued a Cleared decision on April 21, 1998 after a review of 488 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Target Therapeutics devices

Submission Details

510(k) Number K965071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1996
Decision Date April 21, 1998
Days to Decision 488 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
340d slower than avg
Panel avg: 148d · This submission: 488d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MZQ Balloon, Detachable, For Neurovascular Occlusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.