FDA.reportPublic FDA data

Morph DNA

Primary DI
00866749000295
Brand
Morph DNA
Company
Biocardia, Inc.
Model
DNA55-115-30
Catalog number
DNA55-115-30
Device description
Guide Catheter
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192774000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192774000BioCardia 8F Morph DNA Deflectable Guide CatheterBiocardia2020-01-07DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866749000295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866749000295008667490002958667490002950866749000295

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
877688069
Device count
1
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
00866749000271Helical Infusion Catheter00953L00953L2023-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
08718481740330Guidion ShortIMDS Operations B.V.DQY2026-06-01
08718481740347FlowGuideIMDS Operations B.V.DQY2026-06-01
07613327623338AXS LiftStryker CorporationDQY2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
00763000270346Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270353Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
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00763000270384Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
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00763000270292Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
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00763000270315Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270322Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270339Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270391Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07