FDA.reportPublic FDA data

Intra-Art Coronary Artery Retraction Clip

Primary DI
B040CRC51
Brand
Intra-Art Coronary Artery Retraction Clip
Company
GENESEE BIOMEDICAL, INC.
Model
CRC-5
Device description
Coronary Artery Retraction Clip
Published
2017-02-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K882981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K882981000PTI INTRA-ART CORONARY ARTERY RETRACTION CLIPPioneering Technologies, Inc.1988-09-27DWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B040CRC52PackageHIBCC1In Commercial Distribution
B040CRC51PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Coronary artery exposure retractorA sterile, tensionable, surgical instrument designed to be used during cardiac bypass graft anastomosis surgery to provide hands-free (self-retaining) retraction of the fatty surface layer over the myocardium adjacent to the coronary artery, to facilitate exposure of the artery. It is made of stainless steel and is in the form of a clip with leg/prong extensions that uses mechanical spring tension to maintain exposed tissues. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Millimeter

Contacts#

Phone, Email table
PhoneEmail
800 786-4890info@geneseebiomedical.com

Regulatory Flags#

DUNS number
939872651
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B040RPS181100Thoracic Port with Obturator 18x110mmRPS-181102026-03-25
B040RPS18500Thoracic Port with Obturator 18x50mmRPS-18502026-03-25
B040RPS18700Thoracic Port with Obturator 18x70mmRPS-18702026-03-25
B040RPS18900Thoracic Port with Obturator 18x90mmRPS-18902026-03-25
B040TF260TransForm McCarthy Annuloplasty RingTF-262024-12-23
B040TF280TransForm McCarthy Annuloplasty RingTF-282024-12-23
B040TF300TransForm McCarthy Annuloplasty RingTF-302024-12-23
B040TF320TransForm McCarthy Annuloplasty RingTF-322024-12-23
B040TF340TransForm McCarthy Annuloplasty RingTF-342024-12-23
B040TF380TransForm McCarthy Annuloplasty RingTF-382024-12-23
B040TF400TransForm McCarthy Annuloplasty RingTF-402024-12-23
B040TF240TransForm McCarthy Annuloplasty RingTF-242024-12-23
B040TF26TransForm McCarthy Annuloplasty RingTF-262024-12-23
B040TF28TransForm McCarthy Annuloplasty RingTF-282024-12-23
B040TF30TransForm McCarthy Annuloplasty RingTF-302024-12-23
B040TF32TransForm McCarthy Annuloplasty RingTF-322024-12-23
B040TF34TransForm McCarthy Annuloplasty RingTF-342024-12-23
B040TF360TransForm McCarthy Annuloplasty RingTF-362024-12-23
B040TF38TransForm McCarthy Annuloplasty RingTF-382024-12-23
B040TF40TransForm McCarthy Annuloplasty RingTF-402024-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776408732MillenniumAvalign Technologies, Inc.DWS2026-08-03
03661219141778DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
03661219141785DELACROIX-CHEVALIERLANDANGERDWS2026-08-02
14026704916679PILLINGTELEFLEX INCORPORATEDDWS2026-08-01
00190776407438MillenniumAvalign Technologies, Inc.DWS2026-07-31
00190776407513MillenniumAvalign Technologies, Inc.DWS2026-07-31
00190776407315MillenniumAvalign Technologies, Inc.DWS2026-07-28
00190776407360MillenniumAvalign Technologies, Inc.DWS2026-07-28
00190776405830MillenniumAvalign Technologies, Inc.DWS2026-07-26
03661219438663DELACROIX-CHEVALIERLANDANGERDWS2026-07-25
00190776404222MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405748MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776405779MillenniumAvalign Technologies, Inc.DWS2026-07-24
00190776403973MillenniumAvalign Technologies, Inc.DWS2026-07-22
00190776403348MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403683MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776403768MillenniumAvalign Technologies, Inc.DWS2026-07-21
00190776400521MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402051MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776402068MillenniumAvalign Technologies, Inc.DWS2026-07-19
00190776400309MillenniumAvalign Technologies, Inc.DWS2026-07-17
04058749009347NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749010060NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122671NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122725NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749122794NAFehling Instruments GmbH & Co. KGDWS2026-07-17
04058749125917NAFehling Instruments GmbH & Co. KGDWS2026-07-17
00190776397197MillenniumAvalign Technologies, Inc.DWS2026-07-16
00190776395643MillenniumAvalign Technologies, Inc.DWS2026-07-14
00190776396763MillenniumAvalign Technologies, Inc.DWS2026-07-14