Cleared Traditional

K853370 - H-H CATHETER PASSERS(TACL DESIGN (FDA 510(k) Clearance)

Class I Neurology device.

K853370 · Holter-Hausner Intl. · Neurology device
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Sep 1985
Decision
37d
Days
Class 1
Risk

K853370 is an FDA 510(k) clearance for the H-H CATHETER PASSERS(TACL DESIGN. Classified as Instrument, Shunt System Implantation (product code GYK), Class I - General Controls.

Submitted by Holter-Hausner Intl. (Bridgeport, US). The FDA issued a Cleared decision on September 18, 1985 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4545 - 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 Holter-Hausner Intl. devices

Submission Details

510(k) Number K853370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date September 18, 1985
Days to Decision 37 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 148d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GYK Instrument, Shunt System Implantation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 882.4545
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.