Cleared Traditional

K834429 - PERIPHERAL DILATATION ANGIOPLASTY-CATH

K834429 is an FDA 510(k) clearance for PERIPHERAL DILATATION ANGIOPLASTY-CATH, manufactured by American Edwards Laboratories. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K834429

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.

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 346
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