Cleared Special

K011905 - SNIPER ELITE MODEL-OR-E3872XX SERIES

K011905 is an FDA 510(k) clearance for SNIPER ELITE MODEL-OR-E3872XX SERIES, manufactured by Maxxim Medical. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 70-day FDA review.

K011905 · Maxxim Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
70d
Days
Class 2
Risk

K011905 is an FDA 510(k) clearance for the SNIPER ELITE MODEL-OR-E3872XX SERIES. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Maxxim Medical (Athens, US). The FDA issued a Cleared decision on August 28, 2001 after a review of 70 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. 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 Maxxim Medical devices

FDA 510(k) Submission Details - K011905

510(k) Number K011905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2001
Decision Date August 28, 2001
Days to Decision 70 days
Submission Type Special
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
55d faster than avg
Panel avg: 125d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 Peers - DQX Wire, Guide, Catheter

All 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K011905.
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K012534 · Advanced Cardiovascular Systems, Inc. · Jan 2002
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096
K013833 · Guidant Corp. · Jan 2002
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K013092 · Guidant Corp. · Dec 2001
BACK-UP MEIER GUIDEWIRE
K011906 · Boston Scientific Corp · Aug 2001
STREERABLE PTCA GUIDEWIRE
K011968 · Lake Region Mfg., Inc. · Jul 2001
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
K003084 · Concentric Medical, Inc. · May 2001