Cleared Special

SCIMED ANGIOGRAPHIC CATHETERS (K992142) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K992142 · Scimed · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
27d
Days
Class 2
Risk

K992142 is an FDA 510(k) clearance for the SCIMED ANGIOGRAPHIC CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Scimed (Maple Grove, US). The FDA issued a Cleared decision on July 21, 1999 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Scimed devices

Submission Details

510(k) Number K992142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1999
Decision Date July 21, 1999
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 145
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K992142.
TEMPO AQUA ANGIOGRAPHIC CATHETER
K000579 · Cordis Corp. · May 2000
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
K000659 · Merit Medical Systems, Inc. · Mar 2000
CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
K992347 · Cordis Corp. · Oct 1999
CORDIS TEMPO ANGIOGRAPHY CATHETER
K991673 · Cordis Corp. · May 1999
ENVY GUIDING CATHETER
K974774 · Cook, Inc. · Oct 1998
SITESEER ANGIOGRAPHIC CATHETER
K980575 · C.R. Bard, Inc. · May 1998