Cleared Traditional

SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F (K883346) - FDA 510(k) Clearance

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

K883346 · Devices For Vascular Intervention, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
60d
Days
Class 2
Risk

K883346 is an FDA 510(k) clearance for the SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F. 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 September 26, 1988 after a review of 60 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

Submission Details

510(k) Number K883346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1988
Decision Date September 26, 1988
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 154
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K883346.
USCI PTA BALLOON DILATATION CATHETER
K890405 · C.R. Bard, Inc. · Aug 1989
USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP
K890325 · C.R. Bard, Inc. · Mar 1989
STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR
K885247 · Baxter Healthcare Corp · Mar 1989
OMEGA NV(TM) BALLOON DILATATION CATHETER
K882052 · Cook, Inc. · Sep 1988
CORDIS PTA DILATATION CATHETERS
K880612 · Cordis Corp. · Jul 1988
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)
K870215 · Cook, Inc. · Aug 1987