Cleared Traditional

BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS (K910208) - FDA 510(k) Clearance

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

K910208 · Baxter Healthcare Corp · Cardiovascular device
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Apr 1991
Decision
75d
Days
Class 2
Risk

K910208 is an FDA 510(k) clearance for the BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS. 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 1, 1991 after a review of 75 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 K910208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1991
Decision Date April 01, 1991
Days to Decision 75 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
50d faster than avg
Panel avg: 125d · This submission: 75d
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 K910208.
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
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
K910204 · Baxter Healthcare Corp · Apr 1991
DIAVENTIONAL CATHETER
K905297 · Cordis Corp. · Feb 1991
USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER
K905727 · C.R. Bard, Inc. · Feb 1991
MEWISSEN CATHETER
K904788 · Boston Scientific Corp · Dec 1990