Cleared Traditional

K210185 - CardioCurve Steerable Sheath

K210185 is an FDA 510(k) clearance for CardioCurve Steerable Sheath, manufactured by Talon Surgical. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K210185 · Talon Surgical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
179d
Days
Class 2
Risk

K210185 is an FDA 510(k) clearance for the CardioCurve Steerable Sheath. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Talon Surgical (Salt Lake City, US). The FDA issued a Cleared decision on July 23, 2021 after a review of 179 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 Talon Surgical devices

FDA 510(k) Submission Details - K210185

510(k) Number K210185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2021
Decision Date July 23, 2021
Days to Decision 179 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
54d slower than avg
Panel avg: 125d · This submission: 179d
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 432
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K210185.
Prelude Guide Sheath
K211405 · Merit Medical Systems, Inc. · Oct 2021
Halo One Thin-Walled Guiding Sheath
K212708 · C.R. Bard, Inc. · Sep 2021
Aveir Introducer
K211989 · Abbott Medical · Jul 2021
SafeCross Transseptal Puncture and Introducer (TSP/I) System
K203459 · East End Medical I, LLC · Jul 2021
Breezeway II
K210627 · Oscor, Inc. · Jun 2021
AcQCross Qx Integrated Transseptal Dilator/Needle
K210685 · Acutus Medical, Inc. · Apr 2021