Cleared Traditional

K801397 - VENA CAVA CANNULAE

K801397 is an FDA 510(k) clearance for VENA CAVA CANNULAE, manufactured by Texas Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K801397 · Texas Medical Products, Inc. · Cardiovascular device
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Jun 1980
Decision
17d
Days
Class 2
Risk

K801397 is an FDA 510(k) clearance for the VENA CAVA CANNULAE. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Texas Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on June 30, 1980 after a review of 17 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 Texas Medical Products, Inc. devices

FDA 510(k) Submission Details - K801397

510(k) Number K801397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1980
Decision Date June 30, 1980
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 331
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K801397.
ARTERIAL BUBBLE TRAP
K801770 · Delta Medical Industries · Aug 1980
DISPOSABLE SUMP SETS
K801392 · Texas Medical Products, Inc. · Jun 1980
SAPHENOUS VEIN CANNULAE
K801396 · Texas Medical Products, Inc. · Jun 1980
AORTIC AND FEMORAL PERFUSION CANNULAE
K801398 · Texas Medical Products, Inc. · Jun 1980
CARDIOPULMONARY BYPASS TUBING
K801401 · Texas Medical Products, Inc. · Jun 1980
DISPOSABLE PERFUSION SET
K801403 · Texas Medical Products, Inc. · Jun 1980