Cleared Traditional

K873955 - NAMIC ANGIOGRAPHIC SYRINGE

K873955 is an FDA 510(k) clearance for NAMIC ANGIOGRAPHIC SYRINGE, manufactured by North American Instrument Corp.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K873955 · North American Instrument Corp. · Cardiovascular device
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Feb 1988
Decision
130d
Days
Class 2
Risk

K873955 is an FDA 510(k) clearance for the NAMIC ANGIOGRAPHIC SYRINGE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by North American Instrument Corp. (Glens Falls, US). The FDA issued a Cleared decision on February 5, 1988 after a review of 130 days - within the typical 510(k) review window.

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 North American Instrument Corp. devices

FDA 510(k) Submission Details - K873955

510(k) Number K873955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1987
Decision Date February 05, 1988
Days to Decision 130 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
5d slower than avg
Panel avg: 125d · This submission: 130d
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 174
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K873955.
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
ACS INDEFLATOR PLUS (MODIFICATION #2)
K872981 · Advanced Cardiovascular Systems, Inc. · Oct 1987
ANGIOMAT CT INJECTOR
K873687 · Mallinckrodt Group, Inc. · Oct 1987
CAVROPUMP
K871129 · Life-Tech Intl., Inc. · Aug 1987