Cleared Traditional

K800171 - DIAGNOSTIC INTRAVASCULAR CATHETER

K800171 is an FDA 510(k) clearance for DIAGNOSTIC INTRAVASCULAR CATHETER, manufactured by Flomed, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K800171 · Flomed, Inc. · Cardiovascular device
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Feb 1980
Decision
7d
Days
Class 2
Risk

K800171 is an FDA 510(k) clearance for the DIAGNOSTIC INTRAVASCULAR CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Flomed, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1980 after a review of 7 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 Flomed, Inc. devices

FDA 510(k) Submission Details - K800171

510(k) Number K800171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1980
Decision Date February 01, 1980
Days to Decision 7 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
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 425
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K800171.
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