Cleared Traditional

K171206 - D'Vill Introducer

K171206 is an FDA 510(k) clearance for D'Vill Introducer, manufactured by NuMED, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K171206 · NuMED, Inc. · Cardiovascular device
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Oct 2017
Decision
178d
Days
Class 2
Risk

K171206 is an FDA 510(k) clearance for the D'Vill Introducer. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on October 20, 2017 after a review of 178 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 NuMED, Inc. devices

FDA 510(k) Submission Details - K171206

510(k) Number K171206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2017
Decision Date October 20, 2017
Days to Decision 178 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
53d slower than avg
Panel avg: 125d · This submission: 178d
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 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K171206.
Endophys Pressure Sensing Sheath Kit- 8F
K173399 · Endophys Holdings, LLC · Nov 2017
Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath
K172995 · Terumo Medical Corporation · Nov 2017
Performer Introducer
K173068 · Cook Incorporated · Nov 2017
R2P Destination Slender Guiding Sheath
K171491 · Terumo Medical Corporation · Oct 2017
Shoocin Introducer Kit
K172099 · Lepu Medical Technology (Beijing) Co., Ltd. · Oct 2017
Peel-Away Introducer Set
K170020 · Cook Incorporated · Sep 2017