Cleared Traditional

K904788 - MEWISSEN CATHETER

K904788 is an FDA 510(k) clearance for MEWISSEN CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K904788 · Boston Scientific Corp · Cardiovascular device
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Dec 1990
Decision
55d
Days
Class 2
Risk

K904788 is an FDA 510(k) clearance for the MEWISSEN CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on December 17, 1990 after a review of 55 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.

FDA 510(k) Submission Details - K904788

510(k) Number K904788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1990
Decision Date December 17, 1990
Days to Decision 55 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
70d faster than avg
Panel avg: 125d · This submission: 55d
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 498
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K904788.
LAB-SITE
K905017 · Telos Medical Corp. · Jan 1991
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K903199 · Medex, Inc. · Dec 1990
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K904959 · Peripheral Systems Group · Dec 1990
ARTERIAL BLOOD SAMPLING KIT
K902771 · Medex, Inc. · Nov 1990
RSI FEMORAL GUIDING CATHETER
K902943 · Retroperfusion Systems, Inc. · Oct 1990
K904788 · MEWISSEN CATHETER
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