FDA.reportPublic FDA data

EndoCATH

Primary DI
30840143901700
Brand
EndoCATH
Company
ATRICURE, INC.
Model
20-06
Catalog number
FG-0003
Device description
Large Occlusion Balloon Catheter
Published
2021-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070126000OCCLUSION BALLOON CATHETERSentreheart, Inc.2008-02-08DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840143901700PackageGS11In Commercial Distribution
50840143901698PackageGS110In Commercial Distribution
00818354017571PreviousGS10
10840143901690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084014390170030840143901700
5084014390169850840143901698
00818354017571008183540175718183540175710818354017571
1084014390169010840143901690

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-256-7330info@sentreheart.com

Regulatory Flags#

DUNS number
006133784
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
10840143912832Cannula with GuideCSK-6131CSK-6131-32026-05-31
10840143902666cryoICE® SystemA001150A001150-12026-05-27
10840143902673cryoICE® SystemA001150A001150-22026-05-27
10840143902680cryoICE® SystemA001150A001150-32026-05-27
10840143902697cryoICE® SystemA001150A001150-42026-05-27
10840143902703cryoICE® SystemA001150A001150-52026-05-27
10840143902710cryoICE® SystemA001150A001150-62026-05-27
10840143902727cryoICE® SystemA001150A001150-72026-05-27
10840143902734cryoICE® SystemA001150A001150-82026-05-27
30840143904343cryoICE® SystemCMF1A0013592026-05-27
30840143912164AtriCure® cryoICE® BOXACM1A000896-52026-05-27
30840143913703Multifunctional Ablation GeneratorMAGA0013722026-05-27
10840143913761Isolator Synergy™ OSL2A000432-122026-05-12
10840143913440AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO135A0008242026-04-28
10840143913457AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO140A0008252026-04-28
10840143913464AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO145A0008262026-04-28
10840143913471AtriClip PRO® Gillinov-Cosgrove™ LAA Exclusion SystemPRO150A0008272026-04-28
10840143913488AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO235A0009652026-04-28
10840143913495AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO240A0009662026-04-28
10840143913501AtriClip PRO2® Gillinov-Cosgrove™ LAA Exclusion SystemPRO245A0009672026-04-28

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Primary DI, Brand, Company table
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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
00763000270353Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
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00763000270537Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270551Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-08
00763000270216Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270230Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270254Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270292Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270315Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270339Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270391Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270414Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270438Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270476Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270490Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270513Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270582Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270605Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
00763000270667Solitaire™ X-PACKMicro Therapeutics, Inc.DQY2019-11-07
07613327417203AXS Catalyst 7Stryker CorporationDQY2019-05-13
07613327417227AXS Catalyst 7Stryker CorporationDQY2019-05-13
00847536041707PhenomTM 17 CatheterMicro Therapeutics, Inc.DQY2019-04-22
00847536041752PhenomTM 17 CatheterMicro Therapeutics, Inc.DQY2019-04-22
00847536041769PhenomTM 17 CatheterMicro Therapeutics, Inc.DQY2019-04-22
00847536041776PhenomTM 17 CatheterMicro Therapeutics, Inc.DQY2019-04-22