Cleared Traditional

K160747 - Angel Catheter (FDA 510(k) Clearance)

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

K160747 · Bio2 Medical, Inc. · Cardiovascular device
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Jul 2016
Decision
132d
Days
Class 2
Risk

K160747 is an FDA 510(k) clearance for the Angel Catheter. Classified as Short-term Intravascular Filter Catheter (product code PNS), Class II - Special Controls.

Submitted by Bio2 Medical, Inc. (Golden, US). The FDA issued a Cleared decision on July 28, 2016 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3375 - 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 Bio2 Medical, Inc. devices

Submission Details

510(k) Number K160747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2016
Decision Date July 28, 2016
Days to Decision 132 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
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNS Short-term Intravascular Filter Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3375
Definition For Short-term Prevention Of Pulmonary Embolism (pe)
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.