Cleared Traditional

K925813 - DIAGNOSTIC INTRAVASCULAR CATHETER

K925813 is the FDA 510(k) clearance for DIAGNOSTIC INTRAVASCULAR CATHETER by Target Therapeutics. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 491-day FDA review.

K925813 · Target Therapeutics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
491d
Days
Class 2
Risk

K925813 is an FDA 510(k) clearance for the DIAGNOSTIC INTRAVASCULAR 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 March 23, 1994 after a review of 491 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Target Therapeutics devices

Submission Details

510(k) Number K925813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1992
Decision Date March 23, 1994
Days to Decision 491 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
366d slower than avg
Panel avg: 125d · This submission: 491d
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 K925813.
TRANSIT INFUSION CATHETER
K936260 · Cordis Corp. · May 1994
SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION
K934541 · Scimed Life Systems, Inc. · May 1994
SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS
K934581 · Scimed Life Systems, Inc. · Mar 1994
SCIMED 10 FR. LG. LUMEN TRIGUIDE PLUS(TM) GUID CATH
K935654 · Scimed Life Systems, Inc. · Feb 1994
DYE MANAGEMENT SYSTEM
K933700 · Abbott Laboratories · Nov 1993
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
K931479 · Mallinckrodt Medical · Oct 1993