Cleared Traditional

K841587 - CENTRAL VENOUS ACCESS CATHETER CVAC-XX

K841587 is an FDA 510(k) clearance for CENTRAL VENOUS ACCESS CATHETER CVAC-XX, manufactured by Gish Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K841587 · Gish Biomedical, Inc. · Cardiovascular device
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Jun 1984
Decision
107d
Days
Class 2
Risk

K841587 is an FDA 510(k) clearance for the CENTRAL VENOUS ACCESS CATHETER CVAC-XX. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 13, 1984 after a review of 107 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 Gish Biomedical, Inc. devices

FDA 510(k) Submission Details - K841587

510(k) Number K841587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1984
Decision Date June 13, 1984
Days to Decision 107 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
18d faster than avg
Panel avg: 125d · This submission: 107d
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 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K841587.
CRITIKON TRIPLE-LUMEN CENTRAL VENOUS
K842316 · Critikon Company, LLC · Jul 1984
CENTRAL VENOUS CATHETER W/BIG-GARD
K841828 · Norton Performance Plastics Corp. · Jul 1984
RAAF DUAL LUMEN CATHETER
K842176 · Quinton, Inc. · Jul 1984
MICROFUSE INTRAVENOUS CATHETER SET
K840240 · Norton Performance Plastics Corp. · Apr 1984
RIGHT CORONARY GUIDING CATHETER
K833801 · Advanced Cardiovascular Systems, Inc. · Mar 1984
RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI
K840336 · Arrow Intl., Inc. · Feb 1984