FDA.reportPublic FDA data

SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System

Primary DI
08600035053020
Brand
SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System
Company
East End Medical I LLC
Model
3002
Catalog number
3002
Device description
SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System, Medium.
Published
2022-04-13
Public version status
Update
Distribution status
Not 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
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203459000SafeCross Transseptal Puncture and Introducer (TSP/I) SystemEast End Medical I, LLC2021-07-06DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08600035053020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08600035053020086000350530208600035053020

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac septostomy catheter, balloonA flexible tube with an inflatable balloon designed to create or enlarge the atrial septal defect found in the hearts of infants with congenital cardiac malformations. This allows interatrial blood mixing in infants with transposition of the great vessels. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure80 KiloPascal109 KiloPascal
Storage Environment Temperature-30 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
954-507-7887mani@eastendmed.com
9542406694ccruz@eastendmed.com

Regulatory Flags#

DUNS number
118148023
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08600035053037SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System300330032022-04-13
08600035053013SafeCross Transseptal RF Puncture and Steerable Balloon Introducer System300130012022-04-05

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Primary DI, Brand, Company table
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10884450495091Hydrophilic Prelude SNAP™Merit Medical Systems, Inc.DYB2026-09-22
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00884450840597Prelude Roadster™Merit Medical Systems, Inc.DYB2026-08-27