Cleared Traditional

K122506 - SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS

K122506 is an FDA 510(k) clearance for SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, manufactured by Surefire Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K122506 · Surefire Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
31d
Days
Class 2
Risk

K122506 is an FDA 510(k) clearance for the SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Surefire Medical, Inc. (Miami, US). The FDA issued a Cleared decision on September 17, 2012 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 - K122506

510(k) Number K122506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2012
Decision Date September 17, 2012
Days to Decision 31 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
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 732
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K122506.
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