Cleared Traditional

K874037 - ANGIO WASTE FLUIDS DUMP BAG

K874037 is the FDA 510(k) clearance for ANGIO WASTE FLUIDS DUMP BAG by Procedure Products, Inc.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

Device Classification

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 256
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