Cleared Traditional

K874037 - ANGIO WASTE FLUIDS DUMP BAG

K874037 is an FDA 510(k) clearance for ANGIO WASTE FLUIDS DUMP BAG, manufactured by Procedure Products, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K874037 · Procedure Products, Inc. · Cardiovascular device
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Jan 1988
Decision
116d
Days
Class 2
Risk

K874037 is an FDA 510(k) clearance for the ANGIO WASTE FLUIDS DUMP BAG. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Procedure Products, Inc. (Vancouver, US). The FDA issued a Cleared decision on January 29, 1988 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Procedure Products, Inc. devices

FDA 510(k) Submission Details - K874037

510(k) Number K874037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1987
Decision Date January 29, 1988
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 125d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 389
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K874037.
USCI SOFT-TIP ANGIOGRAPHIC CATHETER
K883051 · C.R. Bard, Inc. · Oct 1988
SLIP-COAT(TM) CATHETERS
K882796 · Cook, Inc. · Jul 1988
TARGET THERAPEUTICS STERILE PRODUCTS
K874815 · Target Therapeutics · Feb 1988
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438 · C.R. Bard, Inc. · Nov 1987
GUIDING CATHETER
K873004 · Mallinckrodt Critical Care · Sep 1987
DOUBLE LUMEN CATHETER
K872248 · Cordis Corp. · Aug 1987