Cleared Traditional

K855201 - BARD PARKER PERFUSION CATHETER

K855201 is the FDA 510(k) clearance for BARD PARKER PERFUSION CATHETER by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K855201 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Cardiovascular device
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Apr 1986
Decision
123d
Days
Class 2
Risk

K855201 is an FDA 510(k) clearance for the BARD PARKER PERFUSION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on April 29, 1986 after a review of 123 days - within the typical 510(k) review window.

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: 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 K855201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1985
Decision Date April 29, 1986
Days to Decision 123 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
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 599
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K855201.
CURITY CENTRAL VENOUS CATHETER
K861829 · The Kendal Co. · Jul 1986
VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER
K854610 · Gish Biomedical, Inc. · May 1986
PHARMASEAL DUAL LUMEN CATHETER
K861165 · American Pharmaseal Div. Ahsc · May 1986
CUP MONITORING KIT CVPK-14
K854984 · Medical Components, Inc. · Mar 1986
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO
K851241 · Cook, Inc. · Feb 1986
PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA
K853714 · American Pharmaseal Div. Ahsc · Jan 1986