Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012279212

FEI Number

3012279212

Entity Name

PRYTIME MEDICAL DEVICES, INC.

City/State/Country

Lakewood, CO, US

Establishment Address

575 Union Blvd Suite 107, Lakewood, CO 80228, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Prytime Medical Devices, Inc. (Owner Number: 10050783)

Owner / Operator Contact Address

12 Upper Balcones Rd, Suite 300, Boerne, TX 78006, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

pREBOA-PRO Catheter pREBOA-PRO Catheter ER-REBOA 2 Catheter ER-REBOA PLUS Catheter REBOA Catheter Convenience Set REBOA Catheter Compass Convenience Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2026-01-12
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-06-16
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2020-06-16
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2020-06-16
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2020-06-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-06-16
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2020-06-16
OFC	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2017-05-03

Official Correspondent

Julie Burgett

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Prytime Medical Devices, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3026788751	Prytime Medical Devices, Inc.	Boerne, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051067	LeMaitre Vascular, Inc.	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	2005-05-27
K093847	Thermopeutix, Inc.	DUFLO CATHETER (HEPARIN COATED)	2010-08-25
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2009	Edwards Lifesciences, LLC	2	Edwards Lifesciences*Fogarty Fortis*Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.
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
9616684	Boston Scientific Limited	CORK Munster, IE
9681260	Boston Scientific Limited	GALWAY, IE
3012179728	St. Jude Medical	Roseville, MN, US
3015550451	MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR	Irvine, CA, US
3032916632	BECTON, DICKINSON AND COMPANY	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012279212. Last updated year: 2026. Please use registration number 3012279212 when referencing this establishment in official correspondence.