Cleared Traditional

PTCA BALLOON CATHETERS & ACCESS. (K834433) - FDA 510(k) Clearance

K834433 · Advanced Cardiovascular Systems, Inc. · General & Plastic Surgery device
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Apr 1984
Decision
139d
Days
-
Risk

K834433 is an FDA 510(k) clearance for the PTCA BALLOON CATHETERS & ACCESS..

Submitted by Advanced Cardiovascular Systems, Inc. (Walker, US). The FDA issued a Cleared decision on April 24, 1984 after a review of 139 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K834433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1983
Decision Date April 24, 1984
Days to Decision 139 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 115d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -