FDA.reportPublic FDA data

CrossWise RF Transseptal System

Primary DI
10851498007357
Brand
CrossWise RF Transseptal System
Company
CIRCA Scientific, Inc.
Model
CW-1012W
Published
2024-12-02
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
K241414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241414000CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)Circa Scientific, Inc.2024-09-26DXF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851498007357PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085149800735710851498007357

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
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
30860237000249S-CATH™ Esophageal Temperature ProbeCS-2001 (50cm Length)2016-09-23
10851498007395PeriCross Epicardial Access KitPC-10132025-07-23
10851498007432CrossWise RF Transseptal SystemCW-1085C2025-05-28
10851498007449CrossWise RF Transseptal SystemCW-1085V2025-05-28
10851498007456CrossWise RF Transseptal SystemCW-1013F2025-05-28
00851498007404CIRCA Temperature Monitoring SystemCS-1000 (SW Ver 3.2)2025-02-14
10851498007333CrossWise RF Transseptal SystemCW-1085S2024-12-02
10851498007340CrossWise RF Transseptal SystemCW-1085A2024-12-02
10851498007364CrossWise RF Transseptal SystemCW-1012C2024-12-02
10851498007371CrossWise Multi-Use RF Adapter CableCW-10012024-12-02
00851498007381CIRCA Temperature Monitoring SystemCS-1000 (SW Ver 3.1)2024-10-31
10851498007197CardioCurve Steerable SheathCC-1040S2024-08-01
10851498007203CardioCurve Steerable SheathCC-1040M2024-08-01
10851498007210CardioCurve Steerable SheathCC-1040L2024-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850057445497HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445503HOTWIRE™ RF GUIDEWIREAtraverse Medical, IncDXF2025-10-02
00850057445510HOTWIRE™ 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