Cleared Traditional

K854610 - VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX ...

K854610 is an FDA 510(k) clearance for VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX ..., 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 171-day FDA review.

K854610 · Gish Biomedical, Inc. · Cardiovascular device
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May 1986
Decision
171d
Days
Class 2
Risk

K854610 is an FDA 510(k) clearance for the VASCULAR ACCESS PORT/CATH CAT.#VP-XXXX VASPORT SER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Gish Biomedical, Inc. (Santa Ana, US). The FDA issued a Cleared decision on May 8, 1986 after a review of 171 days - an extended review 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: 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 - K854610

510(k) Number K854610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date May 08, 1986
Days to Decision 171 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
46d slower than avg
Panel avg: 125d · This submission: 171d
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 K854610.
CURITY CENTRAL VENOUS CATHETERIZATION TRAY
K861827 · The Kendal Co. · Jul 1986
CURITY VENOUS CATHETERIZATION KIT
K861828 · The Kendal Co. · Jul 1986
CURITY CENTRAL VENOUS CATHETER
K861829 · The Kendal Co. · Jul 1986
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