Cleared Traditional

K910204 - SWAN-GANZ HI-SHORE THERMO CATH W/AMC(TM)

K910204 is an FDA 510(k) clearance for SWAN-GANZ HI-SHORE THERMO CATH W/AMC(TM), manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K910204 · Baxter Healthcare Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
98d
Days
Class 2
Risk

K910204 is an FDA 510(k) clearance for the SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM). Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on April 24, 1991 after a review of 98 days - within the typical 510(k) review window.

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. 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 - K910204

510(k) Number K910204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1991
Decision Date April 24, 1991
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 306
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K910204.
ZEPHYR INFUSION CATHETER
K911560 · Target Therapeutics · Jul 1991
CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER
K911703 · Cordis Corp. · Jun 1991
BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH
K911367 · Baxter Healthcare Corp · Jun 1991
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
K910208 · Baxter Healthcare Corp · Apr 1991
ACS ANGIOSCOPIC CATHETER
K905715 · Advanced Cardiovascular Systems, Inc. · Mar 1991
SCIMD 7 FR. TRIGUIDE GUIDING CATHETER
K905499 · Scimed Life Systems, Inc. · Feb 1991