Cleared Traditional

CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE (K901691) - FDA 510(k) Clearance

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

K901691 · Cardiovascular Imaging Systems, Inc. · Cardiovascular device
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Jul 1990
Decision
87d
Days
Class 2
Risk

K901691 is an FDA 510(k) clearance for the CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cardiovascular Imaging Systems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on July 6, 1990 after a review of 87 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 Cardiovascular Imaging Systems, Inc. devices

Submission Details

510(k) Number K901691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1990
Decision Date July 06, 1990
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
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 153
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K901691.
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CORDIS SHUTTLE CATHETER
K896308 · Cordis Corp. · Mar 1990