Home GUDID 10851498007463 CrossWise RF Transseptal System
Primary DI 10851498007463
Brand CrossWise RF Transseptal System
Company CIRCA Scientific, Inc.
Model CW-1010C
Published 2026-07-31
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DXF Catheter, Septostomy
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DXF Catheter, Septostomy Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10851498007463 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10851498007463 10851498007463
GMDN Terms# Term, Definition table Term Definition Cardiac transseptal access set A 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.
Regulatory Flags# DUNS number 963223222 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10851498007197 CardioCurve Steerable Sheath CC-1040S 2024-08-01 10851498007203 CardioCurve Steerable Sheath CC-1040M 2024-08-01 10851498007210 CardioCurve Steerable Sheath CC-1040L 2024-08-01 10851498007227 CardioCurve Steerable Sheath CC-1061S 2024-08-01 10851498007234 CardioCurve Steerable Sheath CC-1061M 2024-08-01 10851498007241 CardioCurve Steerable Sheath CC-1061L 2024-08-01 10851498007258 CardioCurve Steerable Sheath CC-1071S 2024-08-01 10851498007265 CardioCurve Steerable Sheath CC-1071M 2024-08-01 10851498007272 CardioCurve Steerable Sheath CC-1071L 2024-08-01 10851498007289 CardioCurve Steerable Sheath CC-1082S 2024-08-01 10851498007296 CardioCurve Steerable Sheath CC-1082M 2024-08-01 10851498007302 CardioCurve Steerable Sheath CC-1082L 2024-08-01 10851498007470 CrossWise RF Transseptal System CW-1013A 2026-07-31 10860237000207 S-CATH™ Esophageal Temperature Probe CS-27ST (Straight) 2019-03-25 10860237000214 S-CATH™ Esophageal Temperature Probe CS-2001 (65cm Length) 2016-09-23 10860237000238 S-CATH™ Esophageal Temperature Probe CS-2007 (65cm Length) 2016-09-23 10860237000245 S-CATH™ Esophageal Temperature Probe CS-2001 (50cm Length) 2016-09-23 30860237000218 S-CATH™ Esophageal Temperature Probe CS-2001 (65cm Length) 2016-09-23 30860237000232 S-CATH™ Esophageal Temperature Probe CS-2007 (65cm Length) 2016-09-23 30860237000249 S-CATH™ Esophageal Temperature Probe CS-2001 (50cm Length) 2016-09-23
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10851498007470 CrossWise RF Transseptal System CIRCA Scientific, Inc. DXF 2026-07-31 00199874352930 Transseptal Puncture Device PROTARYX MEDICAL INC. DXF 2026-07-15 00858769006487 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 00858769006500 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 00858769006524 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 00858769006531 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 00858769006548 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 00858769006555 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 30858769006488 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 00858769006494 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 30858769006501 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 00858769006517 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 30858769006525 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 30858769006532 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 30858769006549 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 30858769006556 SafeSept RF Transseptal Guidewire PPMDM DXF 2026-03-23 00850057445404 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-02 00850057445411 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-02 00850057445428 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-02 00850057445435 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-02 00850057445442 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-02 00850057445459 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-02 00850057445466 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-02 00850057445473 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-02 00850057445480 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-02 00850057445497 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-02 00850057445275 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-01 00850057445282 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-01 00850057445299 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-01 00850057445305 HOTWIRE™ RF GUIDEWIRE Atraverse Medical, Inc DXF 2025-10-01