Cleared Traditional

K884209 - USCI DORROS INFUSION/PROBING CATHETER

K884209 is an FDA 510(k) clearance for USCI DORROS INFUSION/PROBING CATHETER, manufactured by Usci, Div. C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K884209 · Usci, Div. C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
76d
Days
Class 2
Risk

K884209 is an FDA 510(k) clearance for the USCI DORROS INFUSION/PROBING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Usci, Div. C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on December 21, 1988 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K884209

510(k) Number K884209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1988
Decision Date December 21, 1988
Days to Decision 76 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
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 895
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K884209.
MEDIZIV CENTRAL VEIN CATHETER
K884491 · Mediziv Medical Devices, Ltd. · Jun 1989
ACS SELECTIVE INFUSION CATHETER
K885237 · Advanced Cardiovascular Systems, Inc. · Mar 1989
BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SET
K884129 · Bio Medicus, Inc. · Dec 1988
ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES
K883564 · Advanced Cardiovascular Systems, Inc. · Nov 1988
ROTATING HEMOSTATIC VALVE
K883916 · Devices For Vascular Intervention, Inc. · Oct 1988
WILSON BIOMEDICAL CORONARY GUIDING CATHETER
K881793 · Wilson Biomedical, Inc. · Oct 1988
K884209 · USCI DORROS INFUSION/PROBING CATHETER
Download PDF Usci, Div. C.R. Bard,…