Cleared Traditional

K012749 - BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664

K012749 is an FDA 510(k) clearance for BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE C..., manufactured by Biocardia, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K012749 · Biocardia, Inc. · Cardiovascular device
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Jan 2002
Decision
161d
Days
Class 2
Risk

K012749 is an FDA 510(k) clearance for the BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Biocardia, Inc. (South San Francisco, US). The FDA issued a Cleared decision on January 24, 2002 after a review of 161 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 Biocardia, Inc. devices

FDA 510(k) Submission Details - K012749

510(k) Number K012749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2001
Decision Date January 24, 2002
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
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 404
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