Cleared Traditional

K152310 - HeartLight Deflectable Sheath

K152310 is an FDA 510(k) clearance for HeartLight Deflectable Sheath, manufactured by Cardiofocus, Inc.. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K152310 · Cardiofocus, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
194d
Days
Class 2
Risk

K152310 is an FDA 510(k) clearance for the HeartLight Deflectable Sheath. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Cardiofocus, Inc. (Marlborough, US). The FDA issued a Cleared decision on February 24, 2016 after a review of 194 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - 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.

FDA 510(k) Submission Details - K152310

510(k) Number K152310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2015
Decision Date February 24, 2016
Days to Decision 194 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
69d slower than avg
Panel avg: 125d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRA Device Classification - Class 2, Special Controls

Product Code DRA Catheter, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1280
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 - DRA Catheter, Steerable

All 38
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K152310.
AcQGuide Steerable Sheath
K162925 · Acutus Medical, Inc. · Apr 2017
Hansen Medical Magellan Robotic Catheter 9Fr
K160919 · Hansen Medical, Inc. · Sep 2016
Steerable Guide Catheter
K161985 · Abbott Vascular · Aug 2016
Hansen Medical Magellan Robotic Catheter eKit
K153304 · Hansen Medical, Inc. · Feb 2016
Hansen Medical Magellan Robotic Catheter 6Fr and Accessory Components
K151463 · Hansen Medical, Inc. · Aug 2015
MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN ROBOTIC CATHETER 6FR ACCESSORY KIT
K133552 · Hansen Medical · Feb 2014