Cleared Traditional

HIGH PRESSURE TUBING (K941978) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941978 · Abbott Laboratories · Cardiovascular device
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Dec 1994
Decision
243d
Days
Class 2
Risk

K941978 is an FDA 510(k) clearance for the HIGH PRESSURE TUBING. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 13, 1994 after a review of 243 days - an extended review cycle.

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 Abbott Laboratories devices

Submission Details

510(k) Number K941978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1994
Decision Date December 13, 1994
Days to Decision 243 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 125d · This submission: 243d
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 155
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K941978.
EVOLUTION MICROCATHETER
K953114 · Boston Scientific Corp · Sep 1995
BRAUN SELECTIVE ANGIOGRAPHIC CATHETER
K950882 · B.Braun Medical, Inc. · Aug 1995
0.035 IN. WISE WIRE
K942927 · Boston Scientific Corp · Jun 1995
CARDIAC CATHETERIZATION KIT
K932141 · Abbott Laboratories · Sep 1994
CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM
K942939 · Cordis Corp. · Aug 1994
HAND CONTROLLED SYRINGE
K942329 · Abbott Laboratories · Jun 1994