Cleared Special

K011084 - MANDREL GUIDEWIRE ASSEMBLY

K011084 is an FDA 510(k) clearance for MANDREL GUIDEWIRE ASSEMBLY, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 30-day FDA review.

K011084 · Lake Region Mfg., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
30d
Days
Class 2
Risk

K011084 is an FDA 510(k) clearance for the MANDREL GUIDEWIRE ASSEMBLY. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Lake Region Mfg., Inc. (Chaska, US). The FDA issued a Cleared decision on May 10, 2001 after a review of 30 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 Lake Region Mfg., Inc. devices

FDA 510(k) Submission Details - K011084

510(k) Number K011084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2001
Decision Date May 10, 2001
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
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 K011084.
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
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
K010497 · Micro Therapeutics, Inc. · Mar 2001
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
K010511 · Cordis Neurovascular, Inc. · Mar 2001
APPALEAD GW+03XXXXXXR SERIES
K003394 · Nipro Medical Corp. · Jan 2001