Cleared Traditional

K925947 - B-D ARTERIAL BLOOD CONTAINMENT DEVICE

K925947 is the FDA 510(k) clearance for B-D ARTERIAL BLOOD CONTAINMENT DEVICE by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 518
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K925947.
ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE
K934602 · Advanced Cardiovascular Systems, Inc. · Dec 1993
LOC GUIDE WIRE EXTENSION
K934339 · Advanced Cardiovascular Systems, Inc. · Dec 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
SCIMED(R) ENTRE(TM) II PTCA GUIDE WIRE & ACCESSORY
K931514 · Scimed Life Systems, Inc. · Jun 1993