Cleared Traditional

LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM (K981782) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K981782 · Arrow Intl., Inc. · Cardiovascular device
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Aug 1998
Decision
84d
Days
Class 2
Risk

K981782 is an FDA 510(k) clearance for the LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT .... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Walpole, US). The FDA issued a Cleared decision on August 12, 1998 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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

Submission Details

510(k) Number K981782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1998
Decision Date August 12, 1998
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 272
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K981782.
PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)
K984260 · Terumo Medical Corp. · Jan 1999
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K984500 · Cordis Corp. · Dec 1998
MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K983023 · Cordis Corp. · Oct 1998
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K974448 · Cordis Corp. · Feb 1998
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
K973007 · Datascope Corp. · Nov 1997
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K971608 · Cordis Corp. · Jul 1997