CENTERLINE BIOMEDICAL

FDA Device Registration & Listing · Cleveland, OH, US · Registration 3012154226

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
3012154226
FEI Number
3012154226
Entity Name
CENTERLINE BIOMEDICAL
City/State/Country
Cleveland, OH, US
Establishment Address
4535 Renaissance Pkwy, Cleveland, OH 44128, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Centerline Biomedical (Owner Number: 10061285)
Owner / Operator Contact Address
4535 Renaissance Pkwy, Cleveland, OH 44128, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

IOPS Intra-Operative Positioning System IOPS Viewpoint Intra-Operative Positioning System (IOPS®) Intra-Operative Positioning System (IOPS®) Intra-Operative Positioning System (IOPS) IOPS Visionary

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2026-06-11
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2026-06-11
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2026-06-11
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2024-09-18
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2024-09-18
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2023-12-18
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2025-04-15
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2025-04-15
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2025-04-15
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2019-10-04
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2026-02-18
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2026-02-18

Official Correspondent

Carroll Martin

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Centerline Biomedical
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
K150445 Asahi Intecc Co., Ltd. ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) 2015-06-30
K082922 Lake Region Mfg., Inc. FREEWAY AND RAILRUNNER GUIDEWIRES 2008-12-09
K890207 E-Z-Em, Inc. INTERVENTIONAL PRODUCTS - GUIDE WIRES 1989-05-31
K992169 Advanced Cardiovascular Systems, Inc. ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE 1999-10-28
K012534 Advanced Cardiovascular Systems, Inc. HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING 2002-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009 Boston Scientific Corporation 2
Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012154226. Last updated year: 2026. Please use registration number 3012154226 when referencing this establishment in official correspondence.
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