Cleared Traditional

K861165 - PHARMASEAL DUAL LUMEN CATHETER

K861165 is an FDA 510(k) clearance for PHARMASEAL DUAL LUMEN CATHETER, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K861165 · American Pharmaseal Div. Ahsc · Cardiovascular device
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May 1986
Decision
38d
Days
Class 2
Risk

K861165 is an FDA 510(k) clearance for the PHARMASEAL DUAL LUMEN CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Valencia, US). The FDA issued a Cleared decision on May 5, 1986 after a review of 38 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K861165

510(k) Number K861165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1986
Decision Date May 05, 1986
Days to Decision 38 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
87d faster than avg
Panel avg: 125d · This submission: 38d
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 K861165.
CURITY VENOUS CATHETERIZATION KIT
K861828 · The Kendal Co. · Jul 1986
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
BARD PARKER PERFUSION CATHETER
K855201 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1986
CUP MONITORING KIT CVPK-14
K854984 · Medical Components, Inc. · Mar 1986
GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO
K851241 · Cook, Inc. · Feb 1986