Cleared Traditional

K831403 - LOW PROFILE STEERABLE BALLOON DILATA

K831403 is the FDA 510(k) clearance for LOW PROFILE STEERABLE BALLOON DILATA by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K831403 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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Jun 1983
Decision
37d
Days
Class 2
Risk

K831403 is an FDA 510(k) clearance for the LOW PROFILE STEERABLE BALLOON DILATA. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Walker, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 37 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K831403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1983
Decision Date June 08, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
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 243
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K831403.
LOW PROFILE STEERABLE-INTRAOPERATIVE
K833248 · Advanced Cardiovascular Systems, Inc. · Dec 1983
FOGARTY-CHIN PERIPHERAL DILATION CATH
K832474 · American Edwards Laboratories · Sep 1983
FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE
K831659 · American Edwards Laboratories · Aug 1983
FORGARTY CHIN PERIPHERAL INTRAOPERATIVE
K830733 · American Edwards Laboratories · Apr 1983
USCI GRUNTZIG DILACA BALLOON DILATION
K830608 · C.R. Bard, Inc. · Mar 1983
INDEFLATOR
K822245 · Advanced Cardiovascular Systems, Inc. · Aug 1982