Cleared Traditional

K112541 - Z FLEX-270TM STEERABLE SHEATH

K112541 is an FDA 510(k) clearance for Z FLEX-270TM STEERABLE SHEATH, manufactured by Great Batch Medical. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K112541 · Great Batch Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
159d
Days
Class 2
Risk

K112541 is an FDA 510(k) clearance for the Z FLEX-270TM STEERABLE SHEATH. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Great Batch Medical (Plymouth, US). The FDA issued a Cleared decision on February 7, 2012 after a review of 159 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.

View all Great Batch Medical devices

FDA 510(k) Submission Details - K112541

510(k) Number K112541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2011
Decision Date February 07, 2012
Days to Decision 159 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 125d · This submission: 159d
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 21
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K112541.
Steerable Guide Catheter
K172394 · Abbott Vascular · Sep 2017
AcQGuide Steerable Sheath
K162925 · Acutus Medical, Inc. · Apr 2017
Steerable Guide Catheter
K161985 · Abbott Vascular · Aug 2016
STEERABLE GUIDE CATHETER
K112239 · Abbott Vascular · Aug 2011
LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN
K052575 · St Jude Medical · Jan 2006
LYSUS INFUSION SYSTEM
K050472 · Ekos Corp. · Mar 2005