Cleared Traditional

K873012 - INFANT CANNULA

K873012 is an FDA 510(k) clearance for INFANT CANNULA, manufactured by Gresco International, Inc.. The device is a Class 2 Cardiovascular device with product code DQR cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K873012 · Gresco International, Inc. · Cardiovascular device
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May 1988
Decision
272d
Days
Class 2
Risk

K873012 is an FDA 510(k) clearance for the INFANT CANNULA. Classified as Cannula, Catheter (product code DQR), Class II - Special Controls.

Submitted by Gresco International, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 2, 1988 after a review of 272 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1300 - 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 Gresco International, Inc. devices

FDA 510(k) Submission Details - K873012

510(k) Number K873012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date May 02, 1988
Days to Decision 272 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 125d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQR Device Classification - Class 2, Special Controls

Product Code DQR Cannula, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1300
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 - DQR Cannula, Catheter

All 20
Devices cleared under the same product code (DQR) and FDA review panel - the closest regulatory comparables to K873012.
DAIG COLLAPSIBLE STERILE SLEEVE
K884478 · Daig Corp. · Feb 1989
TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER
K884375 · Argon Medical Corp. · Jan 1989
MEDSURG 7 FR. DUAL LUMEN CENTRAL VEIN CATH SYSTEM
K880771 · Medsurg Industries, Inc. · May 1988
7 FR. TRIPLE LUMEN CENTRAL VEIN CATHETERI. SYSTEM
K880776 · Medsurg Industries, Inc. · May 1988
BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER
K874618 · Bentley Laboratories, Inc. · Jan 1988
TORAY ANTHRON ANGIOGRAPHIC CATHETERS
K872983 · Toray Industries (America), Inc. · Nov 1987