CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)— 510(k) K251007
Substantially EquivalentCirca Scientific, Inc.
FDA 510(k) clearance K251007 for CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F), Substantially Equivalent on 2025-05-01. Applicant: Circa Scientific, Inc.. Device class: 2.
Clearance details
- Applicant
- Circa Scientific, Inc.
- Product code
- Code DXF
- Device class
- Class 2
- Regulation
- 21 CFR 870.5175
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Englewood, CO, US
Recent devices under product code DXF
view all- K261745 — LightningWire Transseptal Puncture System (TPS)
- K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
- K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K243193 — Cross Wise Multi-Use RF Adapter Cable
More clearances from Circa Scientific, Inc.
view all- K243954 — PeriCross Epicardial Access Kit
- K241414 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C) +1 more
- K240004 — CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ) +7 more
- K222311 — CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
Adverse events under product code DXF
product code DXF- Death
- 78
- Injury
- 1,126
- Malfunction
- 507
- Other
- 1
- Total
- 1,712
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.