Cleared Traditional

MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH (K897051) - FDA 510(k) Clearance

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

K897051 · Cathlab Corp. · Cardiovascular device
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Mar 1990
Decision
88d
Days
Class 2
Risk

K897051 is an FDA 510(k) clearance for the MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cathlab Corp. (Tustin, US). The FDA issued a Cleared decision on March 16, 1990 after a review of 88 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 Cathlab Corp. devices

Submission Details

510(k) Number K897051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1989
Decision Date March 16, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
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 143
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K897051.
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K895542 · Boston Scientific Corp · Apr 1990
CORDIS SHUTTLE CATHETER
K896308 · Cordis Corp. · Mar 1990
MULTILUMEN CENTRAL VENOUS CATHETER
K885221 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F
K894168 · Baxter Healthcare Corp · Nov 1989
INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING
K891580 · Boston Scientific Corp · Aug 1989