Cleared Traditional

K834463 - LARYNGOTRACHEAL TOPICAL ANES. APPLI (FDA 510(k) Clearance)

K834463 · Sheridan Catheter Corp. · Cardiovascular device
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Jan 1984
Decision
24d
Days
-
Risk

K834463 is an FDA 510(k) clearance for the LARYNGOTRACHEAL TOPICAL ANES. APPLI.

Submitted by Sheridan Catheter Corp. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel. 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 Sheridan Catheter Corp. devices

Submission Details

510(k) Number K834463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1983
Decision Date January 13, 1984
Days to Decision 24 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -