Cleared Traditional

K851241 - GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO

K851241 is an FDA 510(k) clearance for GRECO-HARVEY SURFACTANT BONDED CATHETER..., manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K851241 · Cook, Inc. · Cardiovascular device
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Feb 1986
Decision
365d
Days
Class 2
Risk

K851241 is an FDA 510(k) clearance for the GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cook, Inc. (New Brunswick, US). The FDA issued a Cleared decision on February 26, 1986 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cook, Inc. devices

FDA 510(k) Submission Details - K851241

510(k) Number K851241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1985
Decision Date February 26, 1986
Days to Decision 365 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
240d slower than avg
Panel avg: 125d · This submission: 365d
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 782
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K851241.
PHARMASEAL DUAL LUMEN CATHETER
K861165 · American Pharmaseal Div. Ahsc · May 1986
BARD PARKER PERFUSION CATHETER
K855201 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1986
CUP MONITORING KIT CVPK-14
K854984 · Medical Components, Inc. · Mar 1986
PHARMASEAL OVER-THE NEEDLE ARTERIAL CATHETER & STA
K853714 · American Pharmaseal Div. Ahsc · Jan 1986
ARROW BRACHIAL CENTRAL VENOUS CATH-KIT W/16GA & EC
K854137 · Arrow Intl., Inc. · Dec 1985
GUIDING CATHETER
K853998 · Target Therapeutics · Nov 1985