Cleared Traditional

K802338 - TORQUE CONTROL BALLOON CATHETER

K802338 is an FDA 510(k) clearance for TORQUE CONTROL BALLOON CATHETER, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K802338 · Cordis Corp. · Cardiovascular device

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Oct 1980

Decision

14d

Days

Class 2

Risk

K802338 is an FDA 510(k) clearance for the TORQUE CONTROL BALLOON CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 Cordis Corp. devices

FDA 510(k) Submission Details - K802338

510(k) Number	K802338 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 26, 1980
Decision Date	October 10, 1980
Days to Decision	14 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

111d faster than avg

Panel avg: 125d · This submission: 14d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

DYG Device Classification - Class 2, Special Controls

Product Code	DYG Catheter, Flow Directed
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.1240

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 - DYG Catheter, Flow Directed

All 57

Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K802338.

SWAN-GANZ & EDSLAB HEPARIN COATED CATH.

K812563 · American Edwards Laboratories · Sep 1981

SWAN-GANZ FLOW-DIRECTED THERMODILUTION

K810352 · American Edwards Laboratories · Mar 1981

SWAN-GANZ VIP THERMODILUTION CATHETER

K810124 · American Edwards Laboratories · Feb 1981

CORDIS FLOW DIRECTED BALLOON CATHETER

K801865 · Cordis Corp. · Aug 1980

CATHETER, USCI GRUNTZIG/BALLOON

K782071 · C.R. Bard, Inc. · Dec 1978

CATHETER, PACING/MONITORING

K772059 · Electro-Catheter Corp. · Nov 1977

FDA 510(k) Resources - Cardiovascular

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

Manufacturer of K802338

Cordis Corp.

Mchenry, IL · US

Regulatory profile

315 submissions 281 cleared

89% clearance rate · Active in Cardiovascular

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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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