CrossWise
GUDID 00850021246082
Steerable Transseptal Sheath
KALILA MEDICAL, INC.
Vascular guide-catheter, single-use| Primary Device ID | 00850021246082 |
| NIH Device Record Key | 1346c242-144d-4a85-9743-4fbff6e1bdb9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CrossWise |
| Version Model Number | CW-STS8F25 |
| Company DUNS | 015986592 |
| Company Name | KALILA MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850021246082 [Primary] |
FDA Product Code
| DYB | Introducer, Catheter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-09 |
| Device Publish Date | 2022-02-01 |
Devices Manufactured by KALILA MEDICAL, INC.
| 00850021246082 - CrossWise | 2022-02-09Steerable Transseptal Sheath |
| 00850021246082 - CrossWise | 2022-02-09 Steerable Transseptal Sheath |
| 00861705000425 - Nagare | 2020-03-05 Steerable Sheath, Bi-Directional |
| 00810591020215 - Vado | 2020-03-05 Steerable Sheath, Unidirectional (140 degrees) |
| 00810591020222 - Vado | 2020-03-05 Steerable Sheath, Bidirectional |
| 00810591020239 - Vado | 2020-03-05 Steerable Sheath, Unidirectional (200 degrees) |
Trademark Results [CrossWise]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CROSSWISE 97064578 not registered Live/Pending |
Circa Scientific, Inc. 2021-10-07 |
 CROSSWISE 86863258 5158867 Live/Registered |
ORACLE INTERNATIONAL CORPORATION 2015-12-31 |
 CROSSWISE 76416608 2713270 Dead/Cancelled |
HASBRO, INC. 2002-05-31 |
 CROSSWISE 74439770 1856635 Dead/Cancelled |
Groupware Authors, Inc. 1993-09-24 |
 CROSSWISE 74038898 1693231 Dead/Cancelled |
ANTELOPE ENTERPRISE CO., LTD. 1990-03-16 |
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.