FDA 510(k) Applications Submitted by Jennifer Willner
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K251007 |
04/01/2025 |
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) |
Circa Scientific, Inc. |
| K241414 |
05/17/2024 |
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) |
Circa Scientific, Inc. |
| K142080 |
07/31/2014 |
NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED |
ECOLAB, INC. |
| K142173 |
08/07/2014 |
NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE |
ECOLAB, INC. |
| K182164 |
08/10/2018 |
Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand |
Ecolab Inc. |
| K152522 |
09/03/2015 |
ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes |
ECOLAB, INC. |
| K232809 |
09/12/2023 |
Cross Vascular RF Generator and Footswitch (optional accessory) |
Cross Vascular Inc. |
| K232852 |
09/14/2023 |
Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable |
Cross Vascular Inc. |
| K173164 |
09/29/2017 |
Ecolab POU Water Filter |
Ecolab Inc. |
| K243193 |
09/30/2024 |
Cross WiseÖ Multi-Use RF Adapter Cable |
Circa Scientific, Inc. |
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