Cleared Traditional

K834220 - HYBRID PERIPHERAL DILATION CATHETER

K834220 is the FDA 510(k) clearance for HYBRID PERIPHERAL DILATION CATHETER by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K834220 · American Edwards Laboratories · Cardiovascular device
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Jan 1984
Decision
53d
Days
Class 2
Risk

K834220 is an FDA 510(k) clearance for the HYBRID PERIPHERAL DILATION CATHETER. 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 January 27, 1984 after a review of 53 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 American Edwards Laboratories devices

Submission Details

510(k) Number K834220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1983
Decision Date January 27, 1984
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
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 K834220.
BALLOON DILATION CATHETER
K843501 · Advanced Cardiovascular Systems, Inc. · Oct 1984
PERIPHERAL DILATATION ANGIOPLASTY-CATH
K834429 · American Edwards Laboratories · Aug 1984
ADVANCED CARDIOVASCULAR BALLOON DILATA
K842556 · Advanced Cardiovascular Systems, Inc. · Aug 1984
OLBERT CATHETER SYSTEM
K833616 · Meadox Medicals, Div. Boston Scientific Corp. · Dec 1983
LOW PROFILE STEERABLE-INTRAOPERATIVE
K833248 · Advanced Cardiovascular Systems, Inc. · Dec 1983
FOGARTY-CHIN PERIPHERAL DILATION CATH
K832474 · American Edwards Laboratories · Sep 1983