Cleared Traditional

K880310 - ANGIO DRAPE PACK ACP-010FM

K880310 is an FDA 510(k) clearance for ANGIO DRAPE PACK ACP-010FM, manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K880310 · Arrow Intl., Inc. · Cardiovascular device
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Apr 1988
Decision
88d
Days
Class 2
Risk

K880310 is an FDA 510(k) clearance for the ANGIO DRAPE PACK ACP-010FM. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on April 22, 1988 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K880310

510(k) Number K880310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1988
Decision Date April 22, 1988
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 108
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K880310.
ACS INDEFLATOR P/T 20
K883452 · Advanced Cardiovascular Systems, Inc. · Oct 1988
L-F COILED EXTENSION TUBING
K882329 · Mallinckrodt Group, Inc. · Sep 1988
MEDRAD MICROPROCESSOR CT INJECTION SYSTEM
K880493 · Medrad, 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