Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016948450

FEI Number

3016948450

Entity Name

TRANSIT SCIENTIFIC, LLC

City/State/Country

Salt Lake City, UT, US

Establishment Address

2757 S 300 W, Suite E, Salt Lake City, UT 84115, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Transit Scientific, LLC (Owner Number: 10074833)

Owner / Operator Contact Address

2757 S 300 W, Suite E, Salt Lake City, UT 84115, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231821

PMA Number

N/A

All Registered Proprietary Names

XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter XO Score Percutaneous Transluminal Angioplasty Scoring Catheter XO Cross Coronary XO Cross Support Catheter XO Cross Support Catheter XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter XO Cath Microcatheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2025-01-02
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2020-06-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2022-05-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-06-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-12-28
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2023-01-05
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2023-12-13

Official Correspondent

Ryan Merriner

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Transit Scientific, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

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2011171	Sterigenics US LLC	Los Angeles, CA, US
3006082230	C.R. BARD, INC.	MADISON, GA, US
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016948450. Last updated year: 2026. Please use registration number 3016948450 when referencing this establishment in official correspondence.