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
OTC
false
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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Regulatory Flags#

DUNS number
080088507
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843152100057IOPS Visionary SystemMC-32026-02-24
00843152102051IOPS®H01035H010352024-11-11
00843152103003IOPS™TP-1TP-12020-09-18
00843152103027IOPS®T02111T021112025-03-18
00843152100002IOPS Mobile CartMC-1MC-12020-09-18
00843152104000IOPS™ Software ApplicationSW-1SW-12020-09-18
00843152101030IOPS™RCC-1RCC-12020-09-18
00843152101078IOPS ViewpointC01251C012512024-10-01
00843152101108IOPS ViewpointC00752C007522024-10-01
00843152101115IOPS ViewpointC01252C012522024-10-01
00843152101061IOPS ViewpointC00751C007512024-10-01
00843152102037IOPS™ATW-2ATW-22020-09-18
00843152102013IOPS™SSH-1SSH-12020-10-21
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
00199150062911N/AMEDTRONIC, INC.DQK2026-09-04
00198953213063ComboLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213087CardioLabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953213094Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055668EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055675EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
05415067055682EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19
00885403532040FloTracBecton, Dickinson And CompanyDQK2026-07-31
09349714010877MICROPACE PTY LIMITEDMICROPACE PTY LIMITEDDQK2026-07-21
17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-07-21
17540262110166Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00854277008197NorthStar Mapping SystemImricor Medical Systems, Inc.DQK2026-05-21
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
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQK2026-02-24
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
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
B353UA2251DA1UbiqVueLifesignals, Inc.DQK2025-04-22
B353UA2251SA1UbiqVueLifesignals, Inc.DQK2025-04-22