Cleared Traditional

K992123 - SCIMED IMPULSE ANGIOGRAPHIC CATHETERS

K992123 is an FDA 510(k) clearance for SCIMED IMPULSE ANGIOGRAPHIC CATHETERS, manufactured by Boston Scientific Scimed, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K992123 · Boston Scientific Scimed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
61d
Days
Class 2
Risk

K992123 is an FDA 510(k) clearance for the SCIMED IMPULSE ANGIOGRAPHIC CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 23, 1999 after a review of 61 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 Boston Scientific Scimed, Inc. devices

FDA 510(k) Submission Details - K992123

510(k) Number K992123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1999
Decision Date August 23, 1999
Days to Decision 61 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
64d faster than avg
Panel avg: 125d · This submission: 61d
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 403
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K992123.
PATHFINDER II ANGIOGRAPHIC CATHETER
K990173 · Maxxim Medical · Dec 1999
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
K992631 · Acuson Corp. · Dec 1999
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
K992347 · Cordis Corp. · Oct 1999
RADIFOCUS OPTITORQUE
K992051 · Terumo Medical Corp. · Aug 1999
AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER
K984627 · Arterial Vascular Engineering, Inc. · Jul 1999
SCIMED ANGIOGRAPHIC CATHETERS
K992142 · Scimed · Jul 1999