Cleared Traditional

K981613 - COBE SMARXT TUBING AND CONNECTORS

K981613 is an FDA 510(k) clearance for COBE SMARXT TUBING AND CONNECTORS, manufactured by Cobe Cardiovascular, Inc.. The device is a Class 2 Cardiovascular device with product code DWE cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K981613 · Cobe Cardiovascular, Inc. · Cardiovascular device
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Oct 1998
Decision
173d
Days
Class 2
Risk

K981613 is an FDA 510(k) clearance for the COBE SMARXT TUBING AND CONNECTORS. Classified as Tubing, Pump, Cardiopulmonary Bypass (product code DWE), Class II - Special Controls.

Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on October 26, 1998 after a review of 173 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4390 - 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 Cobe Cardiovascular, Inc. devices

FDA 510(k) Submission Details - K981613

510(k) Number K981613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1998
Decision Date October 26, 1998
Days to Decision 173 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
48d slower than avg
Panel avg: 125d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWE Device Classification - Class 2, Special Controls

Product Code DWE Tubing, Pump, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4390
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 - DWE Tubing, Pump, Cardiopulmonary Bypass

All 12
Devices cleared under the same product code (DWE) and FDA review panel - the closest regulatory comparables to K981613.
JOSTRA HLM TUBING SET
K053025 · Maquet Cardiopulmonary, AG · Nov 2005
PUMP TUBING WITH X-COATING
K022857 · Terumo Cardiovascular Systems Corporation · Sep 2002
PUMP TUBING
K013578 · Terumo Cardiovascular Systems Corp. · Jan 2002
SARNS TEMPERATURE PROBE AND CONNECTOR
K905686 · 3M Health Care, Sarns · Feb 1991
SARNS EVACUPLEGE CATHETER
K842044 · 3M Health Care, Sarns · Aug 1984
MEDRAD HIGH PRESSURE CONECTING TUBE
K810924 · Medrad, Inc. · Apr 1981