Cleared Traditional

K845045 - VENOUS RETURN CATHETER SS-1

K845045 is an FDA 510(k) clearance for VENOUS RETURN CATHETER SS-1, manufactured by Dlp, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K845045 · Dlp, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
96d
Days
Class 2
Risk

K845045 is an FDA 510(k) clearance for the VENOUS RETURN CATHETER SS-1. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on April 3, 1985 after a review of 96 days - within the typical 510(k) review window.

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: 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 Dlp, Inc. devices

FDA 510(k) Submission Details - K845045

510(k) Number K845045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1984
Decision Date April 03, 1985
Days to Decision 96 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
29d faster than avg
Panel avg: 125d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

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 331
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K845045.
ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN
K850917 · Sherwood Medical Co. · May 1985
BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER
K850925 · American Bentley · May 1985
INTRACARDIAC SUMP 12010
K850385 · Dlp, Inc. · Apr 1985
PUL,MONARY ARTERY VENT CATHETER
K845046 · Dlp, Inc. · Apr 1985
STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN
K844137 · Shiley, Inc. · Dec 1984
STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI
K844138 · Shiley, Inc. · Dec 1984