Cleared Traditional

K910429 - SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER

K910429 is an FDA 510(k) clearance for SWAN-GANZ FLOW DIRECTED PRESSURE TD CAT..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K910429

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.

DXO Device Classification - Class 2, Special Controls

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 57
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K910429.
INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER
K924737 · Becton Dickinson Vascular Access, Inc. · Aug 1993
TRANSDUCER, PRESSURE, CATHETER TIP
K920580 · Medamicus, Inc. · Jan 1993
MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN
K915775 · Millar Instruments, Inc. · Apr 1992
MILLAR MIKRO-TIP PULSE TRANSDUCER
K895721 · Millar Instruments, Inc. · Dec 1989
DISPOSABLE CATHETER PRESSURE TRANSDUCER
K894033 · Deseret Medical, Inc. · Oct 1989
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K894286 · Ppg Industries, Inc. · Oct 1989