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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02186223 Completed Interventional Industry-sponsored

The Angel® Catheter Pivotal Clinical Trial

The Angel® Catheter Clinical Trial: Prevention of Pulmonary Embolism in High Risk Subjects

172
Patients (actual)
21
Sites
Prevention
Purpose
Open label
Masking
Condition studied Pulmonary Embolism; Deep Vein Thrombosis; Venous Thromboembolism; Trauma
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Victor Tapson, MD
Sponsor BiO2 Medical (industry)
Started 2015-01-01 → Primary completion 2015-12-01
Primary outcome
Freedom From Clinically Significant PE or Fatal PE During Treatment Period
Secondary outcome
Incidence of Acute Proximal Deep Vein Thrombosis
View full study on ClinicalTrials.gov
K160747 · Angel Catheter
Download PDF FDA Summary Bio2 Medical, Inc.