Cleared Special

Endovascular Dilator and Sets

K210734 · Cook Incorporated · Cardiovascular
Apr 2021
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K210734 is an FDA 510(k) clearance for the Endovascular Dilator and Sets, a Dilator, Vessel, For Percutaneous Catheterization (Class II — Special Controls, product code DRE), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on April 6, 2021, 26 days after receiving the submission on March 11, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1310.

Submission Details

510(k) Number K210734 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2021
Decision Date April 06, 2021
Days to Decision 26 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

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

Similar Devices — DRE Dilator, Vessel, For Percutaneous Catheterization

All 103
ProtekDilate Vascular Access Kit
K253616 · Sorin Group Italia S.R.L. · Dec 2025
VersaCross Connect? Transseptal Dilator
K251325 · Baylis Medical Company, Inc. · May 2025
Micro Ace Gold Advanced Micro Access System
K242229 · Merit Medical Systems, Inc. · Jan 2025
VersaCross Connect? Transseptal Dilator
K241720 · Baylis Medical Company, Inc. · Jul 2024
VersaCross Connect? Transseptal Dilator
K233647 · Baylis Medical Company, Inc. · Dec 2023
Micro Ace? Advanced Micro Access System
K232609 · Merit Medical Systems, Inc. · Sep 2023