Cleared Traditional

K855201 - BARD PARKER PERFUSION CATHETER

K855201 is an FDA 510(k) clearance for BARD PARKER PERFUSION CATHETER, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Cardiovascular device with 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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K855201

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.

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 822
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