Cleared Traditional

K792202 - TROCAR CATHETER/THORACIC CATHETER

K792202 is an FDA 510(k) clearance for TROCAR CATHETER/THORACIC CATHETER, manufactured by Portex, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K792202 · Portex, Inc. · Cardiovascular device
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Nov 1979
Decision
18d
Days
Class 2
Risk

K792202 is an FDA 510(k) clearance for the TROCAR CATHETER/THORACIC CATHETER. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Portex, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 20, 1979 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Portex, Inc. devices

FDA 510(k) Submission Details - K792202

510(k) Number K792202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1979
Decision Date November 20, 1979
Days to Decision 18 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
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 297
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K792202.
CARDIOPULMONARY BYPASS TUBING
K801401 · Texas Medical Products, Inc. · Jun 1980
DISPOSABLE PERFUSION SET
K801403 · Texas Medical Products, Inc. · Jun 1980
SARNS MEDIASTINAL AND PERICARDIAL TUBE
K792070 · 3M Health Care, Sarns · Nov 1979
SHILEY CARDIOPLEGIC SOLUTION DEL SETS
K791947 · Shiley, Inc. · Nov 1979
CARDIOPLEGIA ADMIN. SETS
K791858 · Travenol Laboratories, S.A. · Oct 1979
ARGYLE PEDIATRIC VENA CAVAL CATHETER
K791972 · Sherwood Medical Co. · Oct 1979