Cleared Traditional

K894401 - BALLOON THERMODILUTION CATHETERS

K894401 is an FDA 510(k) clearance for BALLOON THERMODILUTION CATHETERS, manufactured by Worldwide Medical. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K894401 · Worldwide Medical · Cardiovascular device
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Apr 1990
Decision
304d
Days
Class 2
Risk

K894401 is an FDA 510(k) clearance for the BALLOON THERMODILUTION CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Worldwide Medical (Sunrise, US). The FDA issued a Cleared decision on April 19, 1990 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device oversight framework. 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Worldwide Medical devices

FDA 510(k) Submission Details - K894401

510(k) Number K894401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1989
Decision Date April 19, 1990
Days to Decision 304 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 125d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 417
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K894401.
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