Cleared Traditional

MODIFIED ESCHMANN DILATATION CATHETER (K864637) - FDA 510(k) Clearance

K864637 · Eschmann Bros. & Walsh , Ltd. · Cardiovascular device
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Jan 1987
Decision
48d
Days
-
Risk

K864637 is an FDA 510(k) clearance for the MODIFIED ESCHMANN DILATATION CATHETER.

Submitted by Eschmann Bros. & Walsh , Ltd. (Sussex Bn15 8tj, GB). The FDA issued a Cleared decision on January 6, 1987 after a review of 48 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 Eschmann Bros. & Walsh , Ltd. devices

Submission Details

510(k) Number K864637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1986
Decision Date January 06, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -