Cleared Traditional

K792177 - MILLAR MIKRO-TIP CATHETER TRANSDUCER

K792177 is the FDA 510(k) clearance for MILLAR MIKRO-TIP CATHETER TRANSDUCER by Millar Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DXO) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K792177 · Millar Instruments, Inc. · Cardiovascular device
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Nov 1979
Decision
16d
Days
Class 2
Risk

K792177 is an FDA 510(k) clearance for the MILLAR MIKRO-TIP CATHETER TRANSDUCER. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Millar Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1979 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - 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 Millar Instruments, Inc. devices

Submission Details

510(k) Number K792177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1979
Decision Date November 15, 1979
Days to Decision 16 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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.