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FDA 510(k)

XO Score Percutaneous Transluminal Angioplasty Scoring Catheter

K-Number: K193495 · 2020-05-29

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

Device Summary

XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is a medical device manufactured by Transit Scientific. It received FDA 510(k) clearance on 2020-05-29 under approval 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. It is manufactured by Transit Scientific. The 510(k) number is K193495.

When was XO Score Percutaneous Transluminal Angioplasty Scoring Catheter approved by the FDA?

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

What company makes XO Score Percutaneous Transluminal Angioplasty Scoring Catheter?

XO Score Percutaneous Transluminal Angioplasty Scoring Catheter is manufactured by Transit Scientific.

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.

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Other Devices by Transit Scientific

K193420XO Cross Support Catheter

Related Devices (Code: PNO)

K152789FLEX SCORING CATHETERVenturemed Group K172571ULTRASCORE Focused Force PTA BalloonC. R. Bard K163420UltraScore Focused Force PTA BalloonBard Peripheral Vascular, Inc. K163380Serranator Alto PTA Serration Balloon CatheterCagent Vascular, LLC K182713Scoreflex PTA Scoring Balloon CatheterOrbusneich Medical Trading, Inc. K203437Serranator PTA Serration Balloon CatheterCagent Vascular, LLC

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.

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