Cleared Traditional

K112541 - Z FLEX-270TM STEERABLE SHEATH (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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.

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Submission Details

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.

Device Classification

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 40
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K112541.
Globe Introducer (601-01001)
K250529 · Kardium, Inc. · Jun 2025
FARADRIVE™ Steerable Sheath
K233248 · Boston Scientific Corporation · Dec 2023
FlexCath Contour™ Steerable Sheath
K232321 · Medtronic, Inc. · Oct 2023
POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor
K223824 · Boston Scientific Corporation · Mar 2023
MitraClip G4 Steerable Guide Catheter
K221397 · Abbott Medical · Sep 2022
AcQGuide® VUE Steerable Sheath
K221044 · Acutus Medical, Inc. · May 2022