Cleared Traditional

K926243 - ANGIOGRAPHIC CATHETER

K926243 is the FDA 510(k) clearance for ANGIOGRAPHIC CATHETER by Target Therapeutics. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K926243 · Target Therapeutics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
248d
Days
Class 2
Risk

K926243 is an FDA 510(k) clearance for the ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Target Therapeutics (Freemont, US). The FDA issued a Cleared decision on August 16, 1993 after a review of 248 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Target Therapeutics devices

Submission Details

510(k) Number K926243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1992
Decision Date August 16, 1993
Days to Decision 248 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
123d slower than avg
Panel avg: 125d · This submission: 248d
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 292
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K926243.
DYE MANAGEMENT SYSTEM
K933700 · Abbott Laboratories · Nov 1993
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
K931479 · Mallinckrodt Medical · Oct 1993
SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING
K932420 · Scimed Life Systems, Inc. · Aug 1993
SCIMED 6F ANGIOGRAPHIC CATHETER
K932542 · Scimed Life Systems, Inc. · Aug 1993
USCI ANGIOGRAPHIC CATHETER
K932092 · C.R. Bard, Inc. · Jul 1993
BALT GUIDING CATHETER
K925632 · Target Therapeutics · Jun 1993