FDA.reportPublic FDA data

CrossWise RF Transseptal System

Primary DI
10851498007449
Brand
CrossWise RF Transseptal System
Company
CIRCA Scientific, Inc.
Model
CW-1085V
Published
2025-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXFCatheter, Septostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXFCatheter, SeptostomyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251007000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251007000CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)Circa Scientific, Inc.2025-05-01DXF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851498007449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085149800744910851498007449

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac transseptal access setA collection of nonimplantable, invasive devices intended to be used to puncture the interatrial septum during a transseptal catheterization procedure, and to create a conduit for the introduction of various cardiovascular catheters into the left side of the heart. It includes a vascular guide-catheter (which may be referred to as a steerable introducer) with a transseptal needle to create the puncture, and typically includes additional introduction assistive devices necessary for the procedure (e.g., stylet, guidewire, dilator). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963223222
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10851498007197CardioCurve Steerable SheathCC-1040S2024-08-01
10851498007203CardioCurve Steerable SheathCC-1040M2024-08-01
10851498007210CardioCurve Steerable SheathCC-1040L2024-08-01
10851498007227CardioCurve Steerable SheathCC-1061S2024-08-01
10851498007234CardioCurve Steerable SheathCC-1061M2024-08-01
10851498007241CardioCurve Steerable SheathCC-1061L2024-08-01
10851498007258CardioCurve Steerable SheathCC-1071S2024-08-01
10851498007265CardioCurve Steerable SheathCC-1071M2024-08-01
10851498007272CardioCurve Steerable SheathCC-1071L2024-08-01
10851498007289CardioCurve Steerable SheathCC-1082S2024-08-01
10851498007296CardioCurve Steerable SheathCC-1082M2024-08-01
10851498007302CardioCurve Steerable SheathCC-1082L2024-08-01
10851498007463CrossWise RF Transseptal SystemCW-1010C2026-07-31
10851498007470CrossWise RF Transseptal SystemCW-1013A2026-07-31
10860237000207S-CATH™ Esophageal Temperature ProbeCS-27ST (Straight)2019-03-25
10860237000214S-CATH™ Esophageal Temperature ProbeCS-2001 (65cm Length)2016-09-23
10860237000238S-CATH™ Esophageal Temperature ProbeCS-2007 (65cm Length)2016-09-23
10860237000245S-CATH™ Esophageal Temperature ProbeCS-2001 (50cm Length)2016-09-23
30860237000218S-CATH™ Esophageal Temperature ProbeCS-2001 (65cm Length)2016-09-23
30860237000232S-CATH™ Esophageal Temperature ProbeCS-2007 (65cm Length)2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10851498007463CrossWise RF Transseptal SystemCIRCA Scientific, Inc.DXF2026-07-31
10851498007470CrossWise RF Transseptal SystemCIRCA Scientific, Inc.DXF2026-07-31
00199874352930Transseptal Puncture DevicePROTARYX MEDICAL INC.DXF2026-07-15
00858769006487SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006500SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006524SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006531SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006548SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006555SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006488SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006494SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006501SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00858769006517SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006525SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006532SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006549SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
30858769006556SafeSept RF Transseptal GuidewirePPMDMDXF2026-03-23
00850057445404HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445411HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445428HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445435HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445442HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445459HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445466HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445473HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445480HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445275HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-01
00850057445282HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-01
00850057445299HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-01
00850057445305HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-01