Cleared Special

K113737 - SUREFIRE GUIDE SHEATH

K113737 is an FDA 510(k) clearance for SUREFIRE GUIDE SHEATH, manufactured by Surefire Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 65-day FDA review.

K113737 · Surefire Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
65d
Days
Class 2
Risk

K113737 is an FDA 510(k) clearance for the SUREFIRE GUIDE SHEATH. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Surefire Medical, Inc. (Miami, US). The FDA issued a Cleared decision on February 23, 2012 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Surefire Medical, Inc. devices

FDA 510(k) Submission Details - K113737

510(k) Number K113737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2011
Decision Date February 23, 2012
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 339
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K113737.
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K120893 · Boston Scientific Corp · Mar 2012
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K113260 · Concentric Medical, Inc. · Mar 2012
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K113638 · Navilyst Medical, Inc. · Jan 2012
MICROCATHETER
K112124 · Navilyst Medical, Inc. · Aug 2011
MODIFIED CONCENTRIC MICROCATHETER
K111619 · Concentric Medical, Inc. · Jul 2011