Cleared Traditional

K003604 - ADAPTERS WITH X-COATING

K003604 is an FDA 510(k) clearance for ADAPTERS WITH X-COATING, manufactured by Terumo Cardiovascular Systems Corp.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K003604 · Terumo Cardiovascular Systems Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
78d
Days
Class 2
Risk

K003604 is an FDA 510(k) clearance for the ADAPTERS WITH X-COATING. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corp. (Elkton, US). The FDA issued a Cleared decision on February 7, 2001 after a review of 78 days - a notably fast clearance cycle.

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: 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 Terumo Cardiovascular Systems Corp. devices

FDA 510(k) Submission Details - K003604

510(k) Number K003604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2000
Decision Date February 07, 2001
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 K003604.
GISH TUBING AND CONNECTORS WITH GBS COATING
K030077 · Gish Biomedical, Inc. · Mar 2003
ADAPTERS WITH X-COATING
K022918 · Terumo Cardiovascular Systems Corporation · Nov 2002
LV-1 HEMOSTASIS VALVE, MODEL #6789
K021282 · Guidant Corp. · May 2002
MBA
K993057 · Merit Medical Systems, Inc. · Oct 1999
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
K991102 · Guidant Corp. · Jun 1999
HIGH PRESSURE INJECTION LINES
K963749 · Maxxim Medical · Dec 1996