Cleared Traditional

K974640 - COAXIAL DILATOR SET

K974640 is an FDA 510(k) clearance for COAXIAL DILATOR SET, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K974640 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
88d
Days
Class 2
Risk

K974640 is an FDA 510(k) clearance for the COAXIAL DILATOR SET. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on March 13, 1998 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K974640

510(k) Number K974640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1997
Decision Date March 13, 1998
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 79
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K974640.
MERIT MAK (MINI ACCESS KIT)
K031691 · Merit Medical Systems, Inc. · Sep 2003
PERIPHERAL VASCULAR DILATOR
K974617 · Endovascular Instruments, Inc. · Dec 1998
URESIL DILATOR WITH RADIOPAQUE MARKER
K980282 · Uresil Corp. · Apr 1998
EVT EXPANDABLE SHEATH
K970470 · Guidant Cardiac and Vascular Surgery · Jul 1997
CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
K970392 · Cordis Corp. · Apr 1997
FLEXIBLE DILATING SHEATH
K945586 · Med Institute, Inc. · Apr 1997