Cleared Traditional

K873410 - DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE

K873410 is an FDA 510(k) clearance for DISPOSABLE ANGIOGRAPHIC, manufactured by Blood Gas Supply Co.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K873410 · Blood Gas Supply Co. · Cardiovascular device
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Mar 1988
Decision
213d
Days
Class 2
Risk

K873410 is an FDA 510(k) clearance for the DISPOSABLE ANGIOGRAPHIC, CONTROL SYRINGE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Blood Gas Supply Co. (Melrose, US). The FDA issued a Cleared decision on March 25, 1988 after a review of 213 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 Blood Gas Supply Co. devices

FDA 510(k) Submission Details - K873410

510(k) Number K873410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1987
Decision Date March 25, 1988
Days to Decision 213 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 125d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 175
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K873410.
INJECTOR HANDLE WITH SYRINGE
K880987 · Applied Vascular Devices, Inc. · May 1988
MEDRAD MICROPROCESSOR CT INJECTION SYSTEM
K880493 · Medrad, Inc. · Apr 1988
ANGIO DRAPE PACK ACP-010FM
K880310 · Arrow Intl., Inc. · Apr 1988
DISPOSABLE CORONARY CONTROL SYRINGE 12CC
K875196 · Merit Medical Systems, Inc. · Feb 1988
MEDRAD MRI INJECTION SYSTEM
K873173 · Medrad, Inc. · Feb 1988
NAMIC ANGIOGRAPHIC SYRINGE
K873955 · North American Instrument Corp. · Feb 1988