Cleared Traditional

K834429 - PERIPHERAL DILATATION ANGIOPLASTY-CATH

K834429 is the FDA 510(k) clearance for PERIPHERAL DILATATION ANGIOPLASTY-CATH by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K834429 · American Edwards Laboratories · Cardiovascular device
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Aug 1984
Decision
239d
Days
Class 2
Risk

K834429 is an FDA 510(k) clearance for the PERIPHERAL DILATATION ANGIOPLASTY-CATH. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by American Edwards Laboratories (Walker, US). The FDA issued a Cleared decision on August 10, 1984 after a review of 239 days - an extended review 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: 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 American Edwards Laboratories devices

Submission Details

510(k) Number K834429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1983
Decision Date August 10, 1984
Days to Decision 239 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
114d slower than avg
Panel avg: 125d · This submission: 239d
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 K834429.
MEDI-TECH DILATATION CATHETERS
K843383 · Medi-Tech, Inc. · Oct 1984
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY
K841961 · Scimed Life Systems, Inc. · Oct 1984
BALLOON DILATION CATHETER
K843501 · Advanced Cardiovascular Systems, Inc. · Oct 1984
ADVANCED CARDIOVASCULAR BALLOON DILATA
K842556 · Advanced Cardiovascular Systems, Inc. · Aug 1984
HYBRID PERIPHERAL DILATION CATHETER
K834220 · American Edwards Laboratories · Jan 1984
OLBERT CATHETER SYSTEM
K833616 · Meadox Medicals, Div. Boston Scientific Corp. · Dec 1983