CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
FDA 510(k) K251007 · Circa Scientific, Inc.
510(k) numberK251007
Submission
- Device name
- CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
- Applicant
- Circa Scientific, Inc.
Englewood, CO, US - Received
- April 1, 2025
- Decision date
- May 1, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXF – Catheter, Septostomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5175
- Specialty
- Cardiovascular
Other 510(k)s with product code DXF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261745 | LightningWire Transseptal Puncture System (TPS)DXF · Traditional | ElectroWire Medical | 06/26/2026SE |
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135…DXF · Special | Pressure Products Medical Device Manufacturing… | 03/13/2026SE |
| K260292 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)DXF · Special | Atraverse Medical | 02/27/2026SE |
| K252419 | Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)DXF · Traditional | Atraverse Medical, Inc. | 08/27/2025SE |
| K243193 | Cross Wise Multi-Use RF Adapter CableDXF · Special | Circa Scientific, Inc. | 11/26/2024SE |
| K242076 | VersaCross RF WireDXF · Special | Baylis Medical Company | 11/01/2024SE |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)…DXF · Traditional | Circa Scientific, Inc. | 09/26/2024SE |
| K240900 | HOTWIRE RF GuidewireDXF · Traditional | Atraverse Medical | 05/01/2024SE |
| K232852 | Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableDXF · Traditional | Cross Vascular, Inc. | 10/12/2023SE |
| K221528 | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy CatheterDXF · Traditional | Edwards Lifesciences, LLC | 08/22/2022SE |
More from Edwards Lifesciences, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K243954 | PeriCross Epicardial Access KitDYB · Traditional | 04/24/2025SE |
| K243193 | Cross Wise Multi-Use RF Adapter CableDXF · Special | 11/26/2024SE |
| K241414 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)…DXF · Traditional | 09/26/2024SE |
| K240004 | CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath…DYB · Special | 01/31/2024SE |
| K222311 | CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | 05/25/2023SE |
| K200943 | Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | 12/17/2021SE |
| K112376 | S-Cath Esophageal Temperature Probe and Temperature Monitoring SystemFLL · Traditional | 08/31/2011SE |
Questions and answers
When was CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) cleared by the FDA?
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) (K251007) received a 510(k) decision of Substantially Equivalent on May 1, 2025, 30 days after the submission was received.
What is the product code of K251007?
The FDA product code is DXF – Catheter, Septostomy, a Class II (moderate risk) device regulated under 21 CFR 870.5175.