SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
FDA 510(k) K253799 · Pressure Products Medical Device Manufacturing, LLC
510(k) numberK253799
Submission
- Device name
- SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
- Applicant
- Pressure Products Medical Device Manufacturing, LLC
Morton, PA, US - Received
- November 28, 2025
- Decision date
- March 13, 2026
- 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 |
| 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 |
| K251007 | CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C…DXF · Special | Circa Scientific, Inc. | 05/01/2025SE |
| 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 |
|---|---|---|
| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)DRC · Special | 05/17/2024SE |
| K221707 | SafeSept® Transseptal Guidewire (SS-140)DRC · Special | 09/14/2022SE |
| K210328 | SafeSept Blunt NeedleDRC · Special | 03/05/2021SE |
| K181031 | TSI Transseptal IntroducerDYB · Traditional | 10/26/2018SE |
| K172950 | TSN Transseptal NeedleDRC · Traditional | 02/21/2018SE |
| K172934 | Needle Free Transseptal CannulaDRC · Traditional | 02/16/2018SE |
| K172893 | SafeSept Needle Free Transseptal GuidewireDRC · Traditional | 12/21/2017SE |
| K170671 | SafeSept Transseptal GuidewireDRC · Traditional | 10/20/2017SE |
Questions and answers
When was SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) cleared by the FDA?
SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) (K253799) received a 510(k) decision of Substantially Equivalent on March 13, 2026, 105 days after the submission was received.
What is the product code of K253799?
The FDA product code is DXF – Catheter, Septostomy, a Class II (moderate risk) device regulated under 21 CFR 870.5175.