Cleared Traditional

INSITE STEERABLE GUIDEWIRE (K901224) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901224 · Lake Region Mfg., Inc. · Cardiovascular device
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Jun 1990
Decision
89d
Days
Class 2
Risk

K901224 is an FDA 510(k) clearance for the INSITE STEERABLE GUIDEWIRE. 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 June 11, 1990 after a review of 89 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

Submission Details

510(k) Number K901224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1990
Decision Date June 11, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 252
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K901224.
USCI(R) SILK (TM) GUIDE WIRE
K903923 · C.R. Bard, Inc. · Nov 1990
ROADRUNNER WIRE GUIDE
K901899 · Cook, Inc. · Sep 1990
DATASCOPE SLIDEWIRE(TM)
K901347 · Datascope Corp. · Jun 1990
CRAGG CONVERTIBLE WIRE
K897152 · Boston Scientific Corp · Feb 1990
DATASCOPE STEERING HANDLE
K894940 · Datascope Corp. · Nov 1989
CORDIS STEERABLE COATED GUIDEWIRE
K894633 · Cordis Corp. · Oct 1989