Cleared Traditional

K834433 - PTCA BALLOON CATHETERS & ACCESS.

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

FDA 510(k) Submission Details - K834433

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 115d · This submission: 139d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -