Cleared Traditional

K160747 - Angel Catheter

K160747 is an FDA 510(k) clearance for Angel Catheter, manufactured by Bio2 Medical, Inc.. The device is a Class 2 Cardiovascular device with product code PNS cleared through the Traditional 510(k) pathway after a 132-day FDA review.

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

FDA 510(k) Submission Details - K160747

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.

PNS Device Classification - Class 2, Special Controls

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.