Cleared Traditional

K861241 - ANGIOTOPO CATHETER

K861241 is an FDA 510(k) clearance for ANGIOTOPO CATHETER, manufactured by Houston Biomedical, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K861241 · Houston Biomedical, Inc. · Cardiovascular device
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Jan 1987
Decision
279d
Days
Class 2
Risk

K861241 is an FDA 510(k) clearance for the ANGIOTOPO CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Houston Biomedical, Inc. (Houston, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 279 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 Houston Biomedical, Inc. devices

FDA 510(k) Submission Details - K861241

510(k) Number K861241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1986
Decision Date January 06, 1987
Days to Decision 279 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 125d · This submission: 279d
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 308
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K861241.
DOUBLE LUMEN CATHETER
K872248 · Cordis Corp. · Aug 1987
NUMED BALLOON WEDGE PRESSURE CATHETER
K864943 · NuMED, Inc. · Feb 1987
NUMED BALLOON ANGIOGRAPHIC CATHETERS
K864940 · NuMED, Inc. · Feb 1987
CORDIS CONTRAST INJECTION LINES
K864141 · Cordis Corp. · Nov 1986
TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER
K863137 · Terumo Medical Corp. · Oct 1986
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
K862673 · Medtronic Vascular · Sep 1986