Cleared Traditional

K832386 - PERCLUDER DL OCCLUDING BALLOON

K832386 is the FDA 510(k) clearance for PERCLUDER DL OCCLUDING BALLOON by Datascope Corp.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 265

Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K832386.

PERCUTANEOUS ANGIOSCOPE DELIVERY CATH

K842799 · American Edwards Laboratories · Aug 1984

ADVANCED CARDIOVASCULAR-CORONARY GUID

K842195 · Advanced Cardiovascular Systems, Inc. · Jul 1984

DIAGNOSTIC RADIOLOGY CATHETERS

K834459 · American Edwards Laboratories · Feb 1984

ANGIOGRAPHY KIT W/ADDIT. COMPONENTS

K831509 · Mallinckrodt Critical Care · Jun 1983

ANGIOGRAPHIC NEEDLE

K831189 · Medrad, Inc. · May 1983

DIAGNOSTIC INTRAVASCULAR CATHETER

K830415 · Mallinckrodt Critical Care · Apr 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K832386

Datascope Corp.

Walker, MI · US

Regulatory profile

136 submissions 135 cleared

99% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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