Prytime Medical Devices, Inc.

FDA Device Registration & Listing · Boerne, TX, US · Registration 3026788751

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3026788751
FEI Number
3026788751
Entity Name
Prytime Medical Devices, Inc.
City/State/Country
Boerne, TX, US
Establishment Address
12 Upper Balcones Rd., Suite 300, Boerne, TX 78006, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198
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
N
Expiration Date (Year)
2026
510(k) Number
K200459
PMA Number
N/A

All Registered Proprietary Names

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

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
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
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

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
3012279212 PRYTIME MEDICAL DEVICES, INC. Lakewood, CO, 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
3012279212 PRYTIME MEDICAL DEVICES, INC. Lakewood, CO, US
3015550451 MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR Irvine, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026788751. Last updated year: 2026. Please use registration number 3026788751 when referencing this establishment in official correspondence.
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