Scoreflex PTA Scoring Balloon Catheter
K-Number: K182713 · 2019-06-11
Device Summary
Frequently Asked Questions
What is the Scoreflex PTA Scoring Balloon Catheter?
Scoreflex PTA Scoring Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-06-11. The listed applicant is Orbusneich Medical Trading, Inc.. The 510(k) number is K182713.
When did Scoreflex PTA Scoring Balloon Catheter receive FDA 510(k) clearance?
Scoreflex PTA Scoring Balloon Catheter received FDA 510(k) clearance on 2019-06-11, under 510(k) number K182713.
Who is the listed applicant for Scoreflex PTA Scoring Balloon Catheter?
The FDA 510(k) record lists Orbusneich Medical Trading, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Scoreflex PTA Scoring Balloon Catheter?
The FDA product code for Scoreflex PTA Scoring Balloon Catheter is PNO.
Related Clinical Trials
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Other records listing Orbusneich Medical Trading, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: PNO)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.