FDA.reportPublic FDA data

IOPS™

Primary DI
00843152101023
Brand
IOPS™
Company
Centerline Biomedical, Inc.
Model
SCC-1
Catalog number
SCC-1
Device description
IOPS™ Catheter Simple Curve 1
Published
2020-09-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190106000Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire HandleCenterline Biomedical, Inc.2019-06-24DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843152101020PackageGS15Not in Commercial Distribution
00843152101023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084315210102010843152101020
00843152101023008431521010238431521010230843152101023

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Regulatory Flags#

DUNS number
080088507
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843152100002IOPS Mobile CartMC-1MC-12020-09-18
00843152101078IOPS ViewpointC01251C012512024-10-01
00843152101108IOPS ViewpointC00752C007522024-10-01
00843152101115IOPS ViewpointC01252C012522024-10-01
00843152102037IOPS™ATW-2ATW-22020-09-18
00843152102051IOPS®H01035H010352024-11-11
00843152101061IOPS ViewpointC00751C007512024-10-01
00843152100057IOPS Visionary SystemMC-32026-02-24
00843152101030IOPS™RCC-1RCC-12020-09-18
00843152102013IOPS™SSH-1SSH-12020-10-21
00843152103003IOPS™TP-1TP-12020-09-18
00843152103027IOPS®T02111T021112025-03-18
00843152104000IOPS™ Software ApplicationSW-1SW-12020-09-18
10843152102034IOPS™ATW-2ATW-22020-09-18
10843152103024IOPS®T02111T021112025-03-18
10843152102058IOPS®H01035H010352024-11-11
10843152101075IOPS ViewpointC01251C012512024-10-01
10843152101105IOPS ViewpointC00752C007522024-10-01
10843152101112IOPS ViewpointC01252C012522024-10-01
10843152103000IOPS™TP-1TP-12020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
00199874185187Vektor Medical vMap SoftwareVektor Medical, Inc.DQK2026-05-08
00195278620873MACGe Medical Systems Information Technologies, Inc.DQK2026-03-31
00195278507037Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-03-26
00198953107263MACGe Medical Systems Information Technologies, Inc.DQK2026-01-27
00191506052454MDU5 Plus™BOSTON SCIENTIFIC CORPORATIONDQK2025-12-09
17540279200027CardioSTATIcentia Inc.DQK2025-12-08
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
27540279250029CardioSTATIcentia Inc.DQK2024-12-18
27540279250074CardioSTATIcentia Inc.DQK2024-12-18
27540279250142CardioSTATIcentia Inc.DQK2024-12-18
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
17540279105018EARTIcentia Inc.DQK2024-03-26
17540279200072CardioSTATIcentia Inc.DQK2024-03-26
17540279200140CardioSTATIcentia Inc.DQK2024-03-26
00191506033002AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033125AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033194AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033200AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDQK2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDQK2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDQK2023-04-19