FDA.reportPublic FDA data

SoloPace Fusion Sterile Pack

Primary DI
00850056280044
Brand
SoloPace Fusion Sterile Pack
Company
SOLO PACE INC.
Model
K12-12621
Published
2026-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter
LDFElectrode, Pacemaker, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
LDFElectrode, Pacemaker, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252674000Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.2026-01-09DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850056280044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850056280044008500562800448500562800440850056280044

GMDN Terms#

Term, Definition table
TermDefinition
External pacemaker, epicardial pacingAn external pulse generator (EPG) designed to generate periodic electrical cardiac pacing impulses and transmits them to the heart via invasive (percutaneous) leads to stimulate the heart when the sino-atrial (SA) node is not functioning properly or when the heart has a conductive disorder. It is commonly used: 1) in an emergency; 2) during surgery; or 3) following open-heart surgery until the heart recovers. It is not intended for defibrillation or cardioversion. The leads (not included) are inserted into the heart through a major vein (e.g., subclavian) or attached directly to the heart wall.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
138344845
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850056280051SoloPace Fusion KitSOLOFUSE12026-02-05
00850056280006SoloPace Fusion Ground Pad7050910012026-02-05
20850056280055SoloPace Fusion Kit Shipping CaseSOLOFUSE12026-02-05
00850056280020SoloPace EPGSOLOEPG12026-02-02
00850056280013Solo Pace Control SystemSOLORCM2025-01-23
00850056280037Solo Pace Control SystemSOLOEPG1L2025-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
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