FDA.reportPublic FDA data

HeartLight

Primary DI
00868976000147
Brand
HeartLight
Company
CARDIOFOCUS, INC.
Model
18-3356
Catalog number
18-3356
Device description
Deflectable Sheath
Published
2016-06-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRACATHETER, STEERABLE
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRACatheter, SteerableCardiovascular2
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152310000HeartLight Deflectable SheathCardiofocus, Inc.2016-02-24DRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868976000147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868976000147008689760001478689760001470868976000147

GMDN Terms#

Term, Definition table
TermDefinition
Haemostasis valveA noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length75Centimeter
Lumen/Inner Diameter4Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(844)527-3723customerservice@cardiofocus.com

Regulatory Flags#

DUNS number
068966261
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859373007433HeartLight18-500018-50002020-05-19
00859373007440HeartLight18-495218-49522020-05-19
00859373007464HeartLight18-495718-49572020-05-19
00859373007495HeartLight18-503318-50332020-05-19
00868976000116HeartLight18-295918-29592018-10-03
00868976000161HeartLight18-424718-42472018-10-03
00868976000178HeartLight18-4000-27A18-4000-27A2018-10-03
00868976000109HeartLight18-2531-N25018-2531-N2502016-06-15
00868976000123HeartLight18-144718-14472016-06-15
00868976000130HeartLight18-134218-13422016-06-15
00868976000154HeartLightCF980-E10-US18-30552016-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450439392Prelude IDeal™Merit Medical Systems, Inc.DYB2026-10-21
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-20
00821329003455GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00821329003462GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00733132658855GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658879GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658886GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658909GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658916GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658923GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658930GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658947GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658961GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658978GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659029GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659036GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659043GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659050GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659067GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00850291007475Triever LA Transseptal SheathInari Medical, Inc.DYB2024-04-15
00810123710430ClotTriever SheathInari Medical, Inc.DYB2023-12-15
00733132629985GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2023-05-25
00733132628285GORE DRYSEAL FLEX Introducer SheathW. L. Gore & Associates, Inc.DYB2020-07-11