Cleared Traditional

K841482 - PRESSURE CATHETER PLACEMENT SET 50010

K841482 is the FDA 510(k) clearance for PRESSURE CATHETER PLACEMENT SET 50010 by Dlp, Inc.. It is a Class 2 Cardiovascular device (product code DWF) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K841482 · Dlp, Inc. · Cardiovascular device
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Jun 1984
Decision
63d
Days
Class 2
Risk

K841482 is an FDA 510(k) clearance for the PRESSURE CATHETER PLACEMENT SET 50010. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Dlp, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1984 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Dlp, Inc. devices

Submission Details

510(k) Number K841482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1984
Decision Date June 11, 1984
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 231
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K841482.
SHILEY CORONARY CARDIOPLEGIA ADAPTOR
K843542 · Shiley, Inc. · Oct 1984
ARGYLE CUSTOM TUBING PACK
K842889 · Sherwood Medical Co. · Aug 1984
VENOUS CANNULA W/BENT, TIP WIRE
K842375 · Dlp, Inc. · Aug 1984
SARNS 8.0 SOFT ARC CANNULA
K834134 · 3M Health Care, Sarns · Apr 1984
ARGYLE TAPERED VASCULAR SHUNT
K840914 · Sherwood Medical Co. · Apr 1984
3-DAY BIOINDICATOR RELEASE PROCESS FOR
K833830 · Shiley, Inc. · Apr 1984