Cleared Traditional

K923480 - SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA

K923480 is an FDA 510(k) clearance for SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZ..., manufactured by Scimed Life Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K923480 · Scimed Life Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 1992
Decision
83d
Days
Class 2
Risk

K923480 is an FDA 510(k) clearance for the SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZVOUS PTCA. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Maple Grove, US). The FDA issued a Cleared decision on October 6, 1992 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Scimed Life Systems, Inc. devices

FDA 510(k) Submission Details - K923480

510(k) Number K923480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1992
Decision Date October 06, 1992
Days to Decision 83 days
Submission Type Traditional
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
42d faster than avg
Panel avg: 125d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 406
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K923480.
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