Cleared Traditional

K910429 - SWAN-GANZ FLOW DIRECTED PRESSURE TD CAT...

K910429 is the FDA 510(k) clearance for SWAN-GANZ FLOW DIRECTED PRESSURE TD CAT... by Baxter Healthcare Corp. It is a Class 2 Cardiovascular device (product code DXO) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K910429 · Baxter Healthcare Corp · Cardiovascular device
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Jul 1991
Decision
160d
Days
Class 2
Risk

K910429 is an FDA 510(k) clearance for the SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on July 11, 1991 after a review of 160 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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. Standard predicate reliance. 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K910429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1991
Decision Date July 11, 1991
Days to Decision 160 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 125d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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 - DXO Transducer, Pressure, Catheter Tip

All 25
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K910429.
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
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K925638 · Baxter Healthcare Corp · Oct 1993
ULTRASONIC IMAGING CATHETER
K883202 · Boston Scientific Corp · Nov 1988
SENTORR ARTERIAL PRESSURE SENSOR
K880830 · Ohmeda Medical · Aug 1988
VITALERT 2000 VITAL SIGNS MONITOR
K882031 · Draeger Medical, Inc. · Jul 1988