Cleared Traditional

K882329 - L-F COILED EXTENSION TUBING

K882329 is the FDA 510(k) clearance for L-F COILED EXTENSION TUBING by Mallinckrodt Group, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K882329 · Mallinckrodt Group, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
88d
Days
Class 2
Risk

K882329 is an FDA 510(k) clearance for the L-F COILED EXTENSION TUBING. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Mallinckrodt Group, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 2, 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 Mallinckrodt Group, Inc. devices

Submission Details

510(k) Number K882329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1988
Decision Date September 02, 1988
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
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.

Device Classification

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 102
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K882329.
HIGH PRESSURE CONNECTING SETS
K890208 · E-Z-Em, Inc. · May 1989
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
K884913 · Merit Medical Systems, Inc. · Apr 1989
ACS INDEFLATOR P/T 20
K883452 · Advanced Cardiovascular Systems, Inc. · Oct 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