Cleared Traditional

K871011 - SIMPSON PERIPHERAL ATHEROCATH(TM)

K871011 is an FDA 510(k) clearance for SIMPSON PERIPHERAL ATHEROCATH(TM), manufactured by Devices For Vascular Intervention, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K871011 · Devices For Vascular Intervention, Inc. · Cardiovascular device
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May 1987
Decision
62d
Days
Class 2
Risk

K871011 is an FDA 510(k) clearance for the SIMPSON PERIPHERAL ATHEROCATH(TM). Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Devices For Vascular Intervention, Inc. (Redwood City, US). The FDA issued a Cleared decision on May 14, 1987 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Devices For Vascular Intervention, Inc. devices

FDA 510(k) Submission Details - K871011

510(k) Number K871011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1987
Decision Date May 14, 1987
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 367
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K871011.
SCIMED INFLATION DEVICE, MODEL SM 2000
K875064 · Scimed Life Systems, Inc. · Feb 1988
NUMED PTA CATHETERS
K871796 · NuMED, Inc. · Dec 1987
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)
K870215 · Cook, Inc. · Aug 1987
OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE
K862550 · Meadox Surgimed, Inc. · Sep 1986
SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR
K862467 · Shiley, Inc. · Aug 1986
SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER
K854319 · Shiley, Inc. · Mar 1986