Cleared Traditional

ANGIOTOPO CATHETER (K861241) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 144
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K861241.
SLIP-COAT(TM) CATHETERS
K882796 · Cook, Inc. · Jul 1988
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438 · C.R. Bard, Inc. · Nov 1987
DOUBLE LUMEN CATHETER
K872248 · Cordis Corp. · Aug 1987
CORDIS CONTRAST INJECTION LINES
K864141 · Cordis Corp. · Nov 1986
MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER
K862673 · Medtronic Vascular · Sep 1986
SCHNEIDER-SHILEY FLUSHING CATHETER
K862466 · Shiley, Inc. · Aug 1986