Cleared Traditional

K983940 - EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR

K983940 is an FDA 510(k) clearance for EZ-INTRO PERCUTANEOUS CATHETER SHEATH, manufactured by Adam Spence Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K983940 · Adam Spence Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
252d
Days
Class 2
Risk

K983940 is an FDA 510(k) clearance for the EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Adam Spence Corp. (Wall, US). The FDA issued a Cleared decision on July 15, 1999 after a review of 252 days - an extended review 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: 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 Adam Spence Corp. devices

FDA 510(k) Submission Details - K983940

510(k) Number K983940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1998
Decision Date July 15, 1999
Days to Decision 252 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 125d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 563
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K983940.
TFX MEDICAL INTRODUCER KIT
K991647 · Tfx Medical Group · Jan 2000
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
K994252 · Boston Scientific Corp · Jan 2000
INTRODUCER SHEATH, VESSEL DILATOR
K992309 · Boston Scientific Corp · Oct 1999
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET
K990705 · Medamicus, Inc. · Jun 1999
EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR, EMCEE INFUSION INTRODUCER SHEATH SET, EMCEE INF
K983039 · Schneider/Namic · May 1999
SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229
K984062 · Diag Corp. · Mar 1999