XO CROSS CORONARY Support Catheter
FDA 510(k) K214107 · Transit Scientific, LLC
510(k) numberK214107
Submission
- Device name
- XO CROSS CORONARY Support Catheter
- Applicant
- Transit Scientific, LLC
Salt Lake City, UT, US - Received
- December 29, 2021
- Decision date
- April 11, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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| K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP CatheterPNO · Special | 10/18/2022SE |
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Questions and answers
When was XO CROSS CORONARY Support Catheter cleared by the FDA?
XO CROSS CORONARY Support Catheter (K214107) received a 510(k) decision of Substantially Equivalent on April 11, 2022, 103 days after the submission was received.
What is the product code of K214107?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.