Cleared Traditional

K925632 - BALT GUIDING CATHETER

K925632 is the FDA 510(k) clearance for BALT GUIDING CATHETER by Target Therapeutics. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K925632 · Target Therapeutics · Cardiovascular device
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Jun 1993
Decision
232d
Days
Class 2
Risk

K925632 is an FDA 510(k) clearance for the BALT GUIDING 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 June 29, 1993 after a review of 232 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 K925632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1992
Decision Date June 29, 1993
Days to Decision 232 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
107d slower than avg
Panel avg: 125d · This submission: 232d
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 K925632.
ANGIOGRAPHIC CATHETER
K926243 · Target Therapeutics · Aug 1993
SCIMED 6F ANGIOGRAPHIC CATHETER
K932542 · Scimed Life Systems, Inc. · Aug 1993
USCI ANGIOGRAPHIC CATHETER
K932092 · C.R. Bard, Inc. · Jul 1993
CORDIS 7 FRENCH THRULUMEN CATHETER
K922891 · Cordis Corp. · Jun 1993
NYLEX CATHETERS
K930479 · Cordis Corp. · Apr 1993
RETRIEVER 10
K921649 · Target Therapeutics · Mar 1993