Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016171942

FEI Number

3016171942

Entity Name

PROVISIO MEDICAL INC.

City/State/Country

San Diego, CA, US

Establishment Address

10815 Rancho Bernardo Rd, Suite 110, San Diego, CA 92127, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Provisio Medical Inc. (Owner Number: 10090661)

Owner / Operator Contact Address

10815 Rancho Bernardo Rd, Suite 110, San Diego, CA 92127, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233948

PMA Number

N/A

All Registered Proprietary Names

Provisio SLT IVUS System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2024-04-24
OBJ	Catheter, Ultrasound, Intravascular	Cardiovascular	Class 2	870.1200	2024-04-24
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-04-24
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2024-04-24

Official Correspondent

Jeff Pielemeier

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Provisio Medical Inc.

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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3031768596	PIRAEUS MEDICAL, INC.	Maple Grove, MN, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3011142981	Rontis Hellas S.A.	Larisa Thessalia, GR
3010370269	STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD	Cape Town Western Cape, ZA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016171942. Last updated year: 2026. Please use registration number 3016171942 when referencing this establishment in official correspondence.