Cleared Traditional

K871047 - RADIOPAQUE SPHERICAL EMBOLI (RSE) (FDA 510(k) Clearance)

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

K871047 · Interventional Therapeutics Corp. · Neurology device
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May 1987
Decision
66d
Days
Class 2
Risk

K871047 is an FDA 510(k) clearance for the RADIOPAQUE SPHERICAL EMBOLI (RSE). Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Interventional Therapeutics Corp. (Santa Barbara, US). The FDA issued a Cleared decision on May 22, 1987 after a review of 66 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Interventional Therapeutics Corp. devices

Submission Details

510(k) Number K871047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1987
Decision Date May 22, 1987
Days to Decision 66 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 148d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCG Device, Neurovascular Embolization
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.

Regulatory Peers - HCG Device, Neurovascular Embolization

All 183
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