Cleared Traditional

K925947 - B-D ARTERIAL BLOOD CONTAINMENT DEVICE

K925947 is an FDA 510(k) clearance for B-D ARTERIAL BLOOD CONTAINMENT DEVICE, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K925947 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
269d
Days
Class 2
Risk

K925947 is an FDA 510(k) clearance for the B-D ARTERIAL BLOOD CONTAINMENT DEVICE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on August 20, 1993 after a review of 269 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K925947

510(k) Number K925947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1992
Decision Date August 20, 1993
Days to Decision 269 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
144d slower than avg
Panel avg: 125d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 703
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K925947.
LOC GUIDE WIRE EXTENSION
K934339 · Advanced Cardiovascular Systems, Inc. · Dec 1993
AUTOMATIC PULL BACK DEVICE
K933517 · Cardiovascular Imaging Systems, Inc. · Oct 1993
USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING
K933466 · C.R. Bard, Inc. · Oct 1993
ARROW BLOOD CONTAINMENT DEVICE
K924558 · Arrow Intl., Inc. · Aug 1993
NEW HYDROPHILIC COATING FOR WIRE GUIDES
K924385 · Arrow Intl., Inc. · Aug 1993
PSG DIRECTIONAL HYDROPHILIC GUIDE WIRE
K931327 · Peripheral Systems Group · Jul 1993