Cleared Traditional

BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH (K911367) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911367 · Baxter Healthcare Corp · Cardiovascular device
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Jun 1991
Decision
74d
Days
Class 2
Risk

K911367 is an FDA 510(k) clearance for the BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH. 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 June 10, 1991 after a review of 74 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K911367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1991
Decision Date June 10, 1991
Days to Decision 74 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
51d faster than avg
Panel avg: 125d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 142
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K911367.
CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER
K914141 · Cordis Corp. · Oct 1991
CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH
K914007 · Cordis Corp. · Oct 1991
CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER
K911703 · Cordis Corp. · Jun 1991
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
K910204 · Baxter Healthcare Corp · Apr 1991
BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS
K910208 · Baxter Healthcare Corp · Apr 1991
DIAVENTIONAL CATHETER
K905297 · Cordis Corp. · Feb 1991