Cleared Traditional

K801770 - ARTERIAL BUBBLE TRAP

K801770 is an FDA 510(k) clearance for ARTERIAL BUBBLE TRAP, manufactured by Delta Medical Industries. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K801770 · Delta Medical Industries · Cardiovascular device
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Aug 1980
Decision
10d
Days
Class 2
Risk

K801770 is an FDA 510(k) clearance for the ARTERIAL BUBBLE TRAP. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Delta Medical Industries (Mchenry, US). The FDA issued a Cleared decision on August 7, 1980 after a review of 10 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 Delta Medical Industries devices

FDA 510(k) Submission Details - K801770

510(k) Number K801770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date August 07, 1980
Days to Decision 10 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
115d faster than avg
Panel avg: 125d · This submission: 10d
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 305
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K801770.
RIDGID VENA CAVA CANNULAE
K802543 · Texas Medical Products, Inc. · Jan 1981
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K802378 · Bentley Laboratories, Inc. · Oct 1980
PRESSURE GAUGE ACCESSORY KIT/DILATATION
K802261 · Stanco Medical, Inc. · Oct 1980
DISPOSABLE SUMP SETS
K801392 · Texas Medical Products, Inc. · Jun 1980
SAPHENOUS VEIN CANNULAE
K801396 · Texas Medical Products, Inc. · Jun 1980
VENA CAVA CANNULAE
K801397 · Texas Medical Products, Inc. · Jun 1980