Cleared Traditional

K832386 - PERCLUDER DL OCCLUDING BALLOON

K832386 is an FDA 510(k) clearance for PERCLUDER DL OCCLUDING BALLOON, manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K832386 · Datascope Corp. · Cardiovascular device
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Oct 1983
Decision
92d
Days
Class 2
Risk

K832386 is an FDA 510(k) clearance for the PERCLUDER DL OCCLUDING BALLOON. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Datascope Corp. (Walker, US). The FDA issued a Cleared decision on October 19, 1983 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Datascope Corp. devices

FDA 510(k) Submission Details - K832386

510(k) Number K832386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1983
Decision Date October 19, 1983
Days to Decision 92 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
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 389
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K832386.
ADVANCED CARDIOVASCULAR-CORONARY GUID
K842195 · Advanced Cardiovascular Systems, Inc. · Jul 1984
ELECATH HEPARIN-COATED CATHETERS
K841615 · Electro-Catheter Corp. · Jun 1984
DIAGNOSTIC RADIOLOGY CATHETERS
K834459 · American Edwards Laboratories · Feb 1984
COMPRESSAR DISPOSABLE DISC
K831337 · Instromedix, Inc. · Jul 1983
ANGIOGRAPHY KIT W/ADDIT. COMPONENTS
K831509 · Mallinckrodt Critical Care · Jun 1983
DIGICATH
K831171 · Argon Medical Corp. · May 1983