Cleared Traditional

PERIPHERAL ATHERECTOMY SYSTEM (K890515) - FDA 510(k) Clearance

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

K890515 · Intensive Technology, Inc. · Cardiovascular device
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May 1989
Decision
111d
Days
Class 2
Risk

K890515 is an FDA 510(k) clearance for the PERIPHERAL ATHERECTOMY SYSTEM. Classified as Stripper, Artery, Intraluminal (product code DWX), Class II - Special Controls.

Submitted by Intensive Technology, Inc. (San Diego, US). The FDA issued a Cleared decision on May 23, 1989 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4875 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Intensive Technology, Inc. devices

Submission Details

510(k) Number K890515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1989
Decision Date May 23, 1989
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWX Stripper, Artery, Intraluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4875
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.