Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016522967

FEI Number

3016522967

Entity Name

Route 92 Medical, Head Quarters

City/State/Country

San Mateo, CA, US

Establishment Address

155 Bovet Road, Suite 100, San Mateo, CA 94402, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

Route 92 Medical (Owner Number: 10054934)

Owner / Operator Contact Address

155 Bovet Road, Suite 100, San Mateo, CA 94402, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243601

PMA Number

N/A

All Registered Proprietary Names

Base Camp Sheath System 2 Berenstein 80cm Base Camp Sheath System 2 Berenstein 90cm HiPoint reperfusion catheter with Tenzing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2024-10-11
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-10-11
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2020-09-17
QJP	Catheter, Percutaneous, Neurovasculature	Cardiovascular	Class 2	870.1250	2021-11-01
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-04-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-07-11
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2025-05-23

Official Correspondent

Matthew Fortson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Route 92 Medical

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3030088112	Route 92 Medical, West Jordan	W Jordan, UT, US

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-0021-2025	Stryker Neurovascular	2	The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.
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

Similar Registrations

Registration Number	Establishment Name	Location
3031768596	PIRAEUS MEDICAL, INC.	Maple Grove, MN, US
3031311812	TORO NEUROVASCULAR, INC.	Irvine, CA, US
3016800412	ICS MEDICAL DEVICES LTD	Galway Galway (City), IE
3012931345	Stryker Neurovascular	Salt Lake City, UT, US
3003775027	ASAHI INTECC CO., LTD.	SETO Aichi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016522967. Last updated year: 2026. Please use registration number 3016522967 when referencing this establishment in official correspondence.