Cleared Traditional

K030398 - CARDIACASSIST TRANSSEPTAL CANNULA SET

K030398 is the FDA 510(k) clearance for CARDIACASSIST TRANSSEPTAL CANNULA SET by Cardiacassist, Inc.. It is a Class 2 Cardiovascular device (product code DQR) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K030398 · Cardiacassist, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
106d
Days
Class 2
Risk

K030398 is an FDA 510(k) clearance for the CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221. Classified as Cannula, Catheter (product code DQR), Class II - Special Controls.

Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on May 23, 2003 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1300 - 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 Cardiacassist, Inc. devices

Submission Details

510(k) Number K030398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2003
Decision Date May 23, 2003
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQR Cannula, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1300
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 - DQR Cannula, Catheter

All 14
Devices cleared under the same product code (DQR) and FDA review panel - the closest regulatory comparables to K030398.
INTEGRA JARIT HEPARIN CANNULAS, INJECTORS, AND NEEDLES
K131446 · Integra LifeSciences Corporation · Oct 2013
ANGIODYNAMICS, INC., MICRO ACCESS KITS
K051655 · AngioDynamics, Inc. · Sep 2005
RMI INTERNAL MAMMARY ARTERY CANNULA
K960098 · Research Medical, Inc. · Mar 1996
DATASCOPE ARTERIAL CANNULA W/ACCESS PORT
K902674 · Datascope Corp. · Jan 1991
MODIFIED SHILEY FEMORAL VENOUS CANNULA
K894784 · Shiley, Inc. · Mar 1990
RMI ARTERIAL PERFUSION CANNULA
K894243 · Research Medical, Inc. · Sep 1989