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.

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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
Combination Product No
PCCP Authorized No
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 38
Devices cleared under the same product code (DRA) and FDA review panel - the closest regulatory comparables to K112541.
FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH)
K123591 · Medtronic Cryocath, LP · Dec 2012
ARTISAN EXTEND CONTROL CATHETER
K122275 · Hansen Medical · Aug 2012
CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM
K120086 · Cardiosolutions · Apr 2012
STEERABLE GUIDE CATHETER
K112239 · Abbott Vascular · Aug 2011
FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SHEATH (10 FRENCH) MODEL 3FC12, 3FC10
K102176 · Medtronic Cryocath, LP · Sep 2010
MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST
K100789 · Evalve, Inc. · Apr 2010