Cleared Traditional

K890515 - PERIPHERAL ATHERECTOMY SYSTEM

K890515 is an FDA 510(k) clearance for PERIPHERAL ATHERECTOMY SYSTEM, manufactured by Intensive Technology, Inc.. The device is a Class 2 Cardiovascular device with product code DWX cleared through the Traditional 510(k) pathway after a 111-day FDA review.

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

FDA 510(k) Submission Details - K890515

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.

DWX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DWX Stripper, Artery, Intraluminal

All 8
Devices cleared under the same product code (DWX) and FDA review panel - the closest regulatory comparables to K890515.
TRANSLUMINAL ENDARTERECTOMY DEVICE
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OLYMPUS VALVULOTOME W/DETACHABLE TIP
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OLYMPUS VALVULOTOME W/FIXED TIP
K894496 · Olympus Corp. · Oct 1989
SCANLAN ENDARSECTOR
K841521 · Scanlan Intl., Inc. · Aug 1984
HALL ARTERIAL OSCILLATOR
K801063 · American Sterilizer Co. · Sep 1980