Cleared Traditional

K905581 - SILICONE COATED GUIDEWIRES

K905581 is an FDA 510(k) clearance for SILICONE COATED GUIDEWIRES, manufactured by Lake Region Mfg., Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K905581 · Lake Region Mfg., Inc. · Cardiovascular device
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Feb 1991
Decision
69d
Days
Class 2
Risk

K905581 is an FDA 510(k) clearance for the SILICONE COATED GUIDEWIRES. 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 February 19, 1991 after a review of 69 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 Lake Region Mfg., Inc. devices

FDA 510(k) Submission Details - K905581

510(k) Number K905581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1990
Decision Date February 19, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K905581.
QUICKWIRE - HYDROPHILIC COATED GUIDEWIRE
K904582 · Meadox Surgimed, Inc. · Feb 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE
K905548 · Mallinckrodt Medical · Feb 1991
TORQUE HANDLE DEVICE FOR GUIDEWIRE
K905639 · Lake Region Mfg., Inc. · Feb 1991
.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP
K905502 · Advanced Cardiovascular Systems, Inc. · Feb 1991
DATASCOPE INTERLOCK GUIDE WIRE EXTENSION
K905432 · Datascope Corp. · Jan 1991
GUIDEWIRE
K904477 · Datascope Corp. · Dec 1990