Cleared Traditional

K140034 - SUREFIRE GUIDING CATHETER

K140034 is an FDA 510(k) clearance for SUREFIRE GUIDING CATHETER, manufactured by Surefire Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K140034 · Surefire Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2014
Decision
50d
Days
Class 2
Risk

K140034 is an FDA 510(k) clearance for the SUREFIRE GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Surefire Medical, Inc. (Westminster, US). The FDA issued a Cleared decision on February 26, 2014 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surefire Medical, Inc. devices

FDA 510(k) Submission Details - K140034

510(k) Number K140034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2014
Decision Date February 26, 2014
Days to Decision 50 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 125d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQY Catheter, Percutaneous

All 855
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K140034.
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TOTAL ACROSS
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K133177 · Concentric Medical, Inc. · Feb 2014
LEADLINER CS LEAD DELIVERY SYSTEM
K133501 · Vascular Solutions, Inc. · Feb 2014
ENLIGHTN RENAL GUIDE CATHETER
K131592 · St. Jude Medical, Inc. · Jan 2014