Cleared Traditional

K883651 - MILLAR MIKRO-TIP CATHETER PRESSURE TRAN...

K883651 is the FDA 510(k) clearance for MILLAR MIKRO-TIP CATHETER PRESSURE TRAN... by Millar Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K883651 · Millar Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
84d
Days
Class 2
Risk

K883651 is an FDA 510(k) clearance for the MILLAR MIKRO-TIP CATHETER PRESSURE TRANSDUCER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Millar Instruments, Inc. (Houston, US). The FDA issued a Cleared decision on November 18, 1988 after a review of 84 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 Millar Instruments, Inc. devices

Submission Details

510(k) Number K883651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1988
Decision Date November 18, 1988
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
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 266
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K883651.
USCI 7F GUIDE CATHETER
K890420 · C.R. Bard, Inc. · Apr 1989
USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER
K884502 · C.R. Bard, Inc. · Jan 1989
CATH LAB MONITORING CATHETER
K884065 · C.R. Bard, Inc. · Jan 1989
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
K883051 · C.R. Bard, Inc. · Oct 1988
SLIP-COAT(TM) CATHETERS
K882796 · Cook, Inc. · Jul 1988
TARGET THERAPEUTICS STERILE PRODUCTS
K874815 · Target Therapeutics · Feb 1988