Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Angel Catheter

K-Number: K160747 · 2016-07-28

ApplicantBio2 Medical, Inc.
Decision Date2016-07-28
Product CodePNS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Angel Catheter is a medical device manufactured by Bio2 Medical, Inc.. It received FDA 510(k) clearance on 2016-07-28 under approval number K160747. The device is classified under product code PNS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Angel Catheter?

Angel Catheter is a medical device that received FDA 510(k) clearance on 2016-07-28. It is manufactured by Bio2 Medical, Inc.. The 510(k) number is K160747.

When was Angel Catheter approved by the FDA?

Angel Catheter received FDA 510(k) clearance on 2016-07-28, under approval number K160747.

What company makes Angel Catheter?

Angel Catheter is manufactured by Bio2 Medical, Inc..

What is the FDA product code for Angel Catheter?

The FDA product code for Angel Catheter is PNS.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑