Cleared Traditional

K923480 - SCIMED ENTRE PTCA GUIDE WIRE AND RENDEZ...

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

K923480 · Scimed Life Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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

Submission Details

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.

Device Classification

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 291
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K923480.
RETRIEVER 10
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K922105 · C.R. Bard, Inc. · Nov 1992
PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH
K915726 · Baxter Healthcare Corp · Sep 1992
CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER
K921310 · Cordis Corp. · Sep 1992
LUKENS 2-0 BRAIDED SILK SUTURES
K922254 · Quinton, Inc. · Sep 1992