Data / Medical devices / United States / Transit Scientific, LLC

Transit Scientific, LLC: FDA-registered device maker in Salt Lake City, UT, United States, 7 510(k) clearances

Name: Transit Scientific, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Transit Scientific, LLC is registered with the FDA (registration 3016948450) in Salt Lake City, UT, United States. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated June 17, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Transit Scientific, LLC

FDA registration number: 3016948450
Address: 2757 S 300 W Suite E, Salt Lake City, UT, United States, 84115
Owner or operator: Transit Scientific, LLC (10074833)
Roles: Repackager or relabeler
First device listed: June 1, 2020
Registered through: 2026
Brand names listed: XO Cath Microcatheter, XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter, XO Cross Coronary, XO Cross Support Catheter, XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score Percutaneous Transluminal Angioplasty Scoring Catheter

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Continuous Flush	KRA	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Repackager or relabeler	accessdata.fda.gov
Catheter, Percutaneous, Cutting/Scoring	PNO	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 17, 2024	K232258	XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter	PNO	Substantially Equivalent	Transit Scientific, LLC	accessdata.fda.gov
November 29, 2023	K231821	XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)	KRA	Substantially Equivalent	Transit Scientific, LLC	accessdata.fda.gov
October 18, 2022	K221986	XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter	PNO	Substantially Equivalent	Transit Scientific, LLC	accessdata.fda.gov
April 11, 2022	K214107	XO CROSS CORONARY Support Catheter	DQY	Substantially Equivalent	Transit Scientific, LLC	accessdata.fda.gov
October 21, 2021	K210322	XO Cross Support Catheter	DQY	Substantially Equivalent	Transit Scientific, LLC	accessdata.fda.gov
May 29, 2020	K193495	XO Score Percutaneous Transluminal Angioplasty Scoring Catheter	PNO	Substantially Equivalent	Transit Scientific	accessdata.fda.gov
May 6, 2020	K193420	XO Cross Support Catheter	DQY	Substantially Equivalent	Transit Scientific	accessdata.fda.gov

Compare with other makers

Updated June 17, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.