Cleared Traditional

K902674 - DATASCOPE ARTERIAL CANNULA W/ACCESS PORT

K902674 is an FDA 510(k) clearance for DATASCOPE ARTERIAL CANNULA W/ACCESS PORT, manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with product code DQR cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K902674 · Datascope Corp. · Cardiovascular device
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Jan 1991
Decision
212d
Days
Class 2
Risk

K902674 is an FDA 510(k) clearance for the DATASCOPE ARTERIAL CANNULA W/ACCESS PORT. Classified as Cannula, Catheter (product code DQR), Class II - Special Controls.

Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on January 16, 1991 after a review of 212 days - an extended review cycle.

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 Datascope Corp. devices

FDA 510(k) Submission Details - K902674

510(k) Number K902674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1990
Decision Date January 16, 1991
Days to Decision 212 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQR Device Classification - Class 2, Special Controls

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 18
Devices cleared under the same product code (DQR) and FDA review panel - the closest regulatory comparables to K902674.
ANGIODYNAMICS, INC., MICRO ACCESS KITS
K051655 · AngioDynamics, Inc. · Sep 2005
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
K030398 · Cardiacassist, Inc. · May 2003
RMI INTERNAL MAMMARY ARTERY CANNULA
K960098 · Research Medical, Inc. · Mar 1996
MODIFIED SHILEY FEMORAL VENOUS CANNULA
K894784 · Shiley, Inc. · Mar 1990
RMI ARTERIAL PERFUSION CANNULA
K894243 · Research Medical, Inc. · Sep 1989
DAIG COLLAPSIBLE STERILE SLEEVE
K884478 · Daig Corp. · Feb 1989