FDA.reportPublic FDA data

Helical Infusion Catheter

Primary DI
00866749000271
Brand
Helical Infusion Catheter
Company
Biocardia, Inc.
Model
00953L
Catalog number
00953L
Device description
Catheter, percutaneous
Published
2023-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866749000271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866749000271008667490002718667490002710866749000271

GMDN Terms#

Term, Definition table
TermDefinition
Fluid/device delivery cardiac catheterA sterile, steerable, flexible tube containing electrodes intended to be introduced percutaneously into the heart chambers in order to provide a pathway for the controlled delivery and support of a selective infusion of fluids or transvenous devices to the heart (e.g., the coronary sinus) and coronary vasculature. It may also be used in the evaluation of cardiac arrhythmias from endocardial and intravascular sites. It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite and have an actuator mechanism located at the proximal end used to steer the tip in the desired direction. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
877688069
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866749000202Morph Universal Deflectable Guide Catheter00895008952016-10-10
00866749000240Morph AccessPro Steerable IntroducerMAP645MAP6452016-10-10
00866749000257Morph AccessPro Steerable IntroducerMAP690MAP6902016-10-10
00850007221003Avance Steerable IntroducerAVA85-115-20AVA85-115-202023-07-18
00850007221010Avance Steerable IntroducerAVA85-115-30AVA85-115-302023-07-18
00850007221027Avance Steerable CatheterAVA85-115-50AVA85-115-502023-07-18
00866749000295Morph DNADNA55-115-30DNA55-115-302023-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
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08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
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