Cleared Traditional

K903606 - GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE I...

K903606 is the FDA 510(k) clearance for GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE I... by North American Instrument Corp.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K903606 · North American Instrument Corp. · Cardiovascular device
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Sep 1990
Decision
59d
Days
Class 2
Risk

K903606 is an FDA 510(k) clearance for the GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by North American Instrument Corp. (Glens Falls, US). The FDA issued a Cleared decision on September 27, 1990 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 North American Instrument Corp. devices

Submission Details

510(k) Number K903606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1990
Decision Date September 27, 1990
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 247
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K903606.
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.
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K897106 · Boston Scientific Corp · Oct 1990
SMALL VESSEL BALLOON DILATATION CATHETER
K897124 · Boston Scientific Corp · Jul 1990
MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS
K901018 · Boston Scientific Corp · May 1990
LE PTA CATHETER
K894250 · Baxter Healthcare Corp · Mar 1990