Cleared Special

K081049 - FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12

K081049 is an FDA 510(k) clearance for FLEXCATH STEERABLE SHEATH & DILATOR, manufactured by Cryocath Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DRA cleared through the Special 510(k) pathway after a 74-day FDA review.

K081049 · Cryocath Technologies, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
74d
Days
Class 2
Risk

K081049 is an FDA 510(k) clearance for the FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12. Classified as Catheter, Steerable (product code DRA), Class II - Special Controls.

Submitted by Cryocath Technologies, Inc. (Galisteo, US). The FDA issued a Cleared decision on June 27, 2008 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1280 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cryocath Technologies, Inc. devices

FDA 510(k) Submission Details - K081049

510(k) Number K081049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2008
Decision Date June 27, 2008
Days to Decision 74 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 125d · This submission: 74d
Pathway characteristics
Modification to existing cleared device.

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 K081049.
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
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
K040165 · St Jude Medical · May 2004