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

FDA 510(k)

XO Score Percutaneous Transluminal Angioplasty Scoring Catheter

K-Number: K193495 · 2020-05-29

Decision Date2020-05-29
Product CodePNO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Transit Scientific. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K193495. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XO Score Percutaneous Transluminal Angioplasty Scoring Catheter?

XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is Transit Scientific. The 510(k) number is K193495.

When did XO Score Percutaneous Transluminal Angioplasty Scoring Catheter receive FDA 510(k) clearance?

XO Score Percutaneous Transluminal Angioplasty Scoring Catheter received FDA 510(k) clearance on 2020-05-29, under 510(k) number K193495.

Who is the listed applicant for XO Score Percutaneous Transluminal Angioplasty Scoring Catheter?

The FDA 510(k) record lists Transit Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XO Score Percutaneous Transluminal Angioplasty Scoring Catheter?

The FDA product code for XO Score Percutaneous Transluminal Angioplasty Scoring 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 Transit Scientific 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.

View all 7 devices →

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.