Cleared Traditional

K963749 - HIGH PRESSURE INJECTION LINES

K963749 is an FDA 510(k) clearance for HIGH PRESSURE INJECTION LINES, manufactured by Maxxim Medical. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K963749 · Maxxim Medical · Cardiovascular device
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Dec 1996
Decision
90d
Days
Class 2
Risk

K963749 is an FDA 510(k) clearance for the HIGH PRESSURE INJECTION LINES. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Maxxim Medical (Fort Worth, US). The FDA issued a Cleared decision on December 17, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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 Maxxim Medical devices

FDA 510(k) Submission Details - K963749

510(k) Number K963749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1996
Decision Date December 17, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 85
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K963749.
ADAPTERS WITH X-COATING
K003604 · Terumo Cardiovascular Systems Corp. · Feb 2001
MBA
K993057 · Merit Medical Systems, Inc. · Oct 1999
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
K991102 · Guidant Corp. · Jun 1999
HEMO-VALVE
K955554 · North American Instrument Corp. · Mar 1996
QUEST VEIN GRAFT PERFUSION SET
K952531 · Quest Medical, Inc. · Aug 1995
BRAUN MANIFOLD
K942391 · B.Braun Medical, Inc. · Jun 1995