CARTO VIZIGO
- Primary DI
- 10846835026252
- Brand
- CARTO VIZIGO
- Company
- Biosense Webster Inc
- Model
- D138504
- Catalog number
- D138504
- Device description
- CARTO VIZIGO Bi-Directional Guiding Sheath
- Published
- 2026-05-11
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Contact Domains#
its.jnj.comProduct Codes#
| Code | Name |
|---|---|
| DYB | Introducer, catheter |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DYB | Introducer, Catheter | Cardiovascular | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K170997 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10846835026252 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10846835026252 | 10846835026252 |
GMDN Terms#
| Term | Definition |
|---|---|
| Vascular guide-catheter, single-use | A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Do not use if package is damaged |
| Special Storage Condition, Specify | 0 | 0 | Keep Dry |
| Special Storage Condition, Specify | 0 | 0 | Keep out of direct sunlight |
| Storage Environment Temperature | 0 | 0 |
Contacts#
| Phone | |
|---|---|
| +1(800)729-9010 | RA-BWIUS-Complaints@its.jnj.com |
Regulatory Flags#
- DUNS number
- 020163218
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 10846835026269 | CARTO VIZIGO | D138505 | D138505 | 2026-05-11 |
| 10846835026726 | Dual Energy Thermocool Smarttouch SF Catheter | D134711 | D134711 | 2026-07-09 |
| 10846835026733 | Dual Energy Thermocool Smarttouch SF Catheter | D134712 | D134712 | 2026-07-09 |
| 10846835026764 | Dual Energy Thermocool Smarttouch SF Catheter | D134713 | D134713 | 2026-07-09 |
| 10846835026795 | Dual Energy Thermocool Smarttouch SF Catheter | D134811 | D134811 | 2026-07-09 |
| 10846835026825 | Dual Energy Thermocool Smarttouch SF Catheter | D134812 | D134812 | 2026-07-09 |
| 10846835026856 | Dual Energy Thermocool Smarttouch SF Catheter | D134813 | D134813 | 2026-07-09 |
| 10846835026887 | Dual Energy Thermocool Smarttouch SF Catheter | D134814 | D134814 | 2026-07-09 |
| 10846835026917 | Dual Energy Thermocool Smarttouch SF Catheter | D134815 | D134815 | 2026-07-09 |
| 10846835010121 | Sterile Interface Cable | D133701 | D133701 | 2024-12-11 |
| 10846835016796 | TX eco EXT Cable | D135703 | D135703 | 2023-10-04 |
| 10846835000184 | N/A | C10MR10MSTKS | C10MR10MSTKS | 2017-09-13 |
| 10846835000191 | N/A | C5MHDTCMHS | C5MHDTCMHS | 2017-09-13 |
| 10846835000207 | N/A | C5MHNAVMHS | C5MHNAVMHS | 2017-09-13 |
| 10846835000214 | N/A | C5MHREFMHS | C5MHREFMHS | 2017-09-13 |
| 10846835003666 | N/A | C6MR10EPTRS | C6MR10EPTRS | 2017-09-13 |
| 10846835003789 | Carto 3 | CB3410CT | CB3410CT | 2016-09-16 |
| 10846835003796 | Carto 3 | CB3412CT | CB3412CT | 2016-09-16 |
| 10846835003802 | Carto 3 | CB3434CT | CB3434CT | 2016-09-16 |
| 10846835003826 | Carto 3 | CG2025CT | CG2025CT | 2016-09-16 |
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|---|---|---|---|---|
| 00884450840610 | Prelude Roadster™ | Merit Medical Systems, Inc. | DYB | 2026-10-20 |
| 00821329003455 | GORE GUIDRA Steerable Sheath | Greatbatch Ltd | DYB | 2026-10-14 |
| 00821329003462 | GORE GUIDRA Steerable Sheath | Greatbatch Ltd | DYB | 2026-10-14 |
| 00733132658855 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658862 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658879 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658886 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658893 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658909 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658916 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658923 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658930 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658947 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658954 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658961 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658978 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658985 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132658992 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659005 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659012 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659029 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659036 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659043 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659050 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00733132659067 | GORE® DrySeal Flex Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2024-12-02 |
| 00850291007475 | Triever LA Transseptal Sheath | Inari Medical, Inc. | DYB | 2024-04-15 |
| 00810123710430 | ClotTriever Sheath | Inari Medical, Inc. | DYB | 2023-12-15 |
| 00733132629985 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2023-05-25 |
| 00733132628285 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2020-07-11 |
| 00733132628308 | GORE DRYSEAL FLEX Introducer Sheath | W. L. Gore & Associates, Inc. | DYB | 2020-07-11 |