MITRACLIP SGC0701
GUDID 08717648231025
Steerable Guide Catheter
ABBOTT VASCULAR INC.
Vascular guide-catheter, single-use| Primary Device ID | 08717648231025 |
| NIH Device Record Key | 1a16471f-6d50-49e1-8431-98cf99991d55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MITRACLIP |
| Version Model Number | SGC0701 |
| Catalog Number | SGC0701 |
| Company DUNS | 964569052 |
| Company Name | ABBOTT VASCULAR 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 | false |
| 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
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Handle with care. Store in original packaging. Keep dry. Keep away from sunlight. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717648231025 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K190167
FDA Product Code
| DRA | CATHETER, STEERABLE |
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 | 2019-11-19 |
| Device Publish Date | 2019-11-11 |
On-Brand Devices [MITRACLIP]
| 08717648226366 | MitraClip XTR Clip Delivery System |
| 08717648226342 | MitraClip NTR Clip Delivery System |
| 08717648216800 | MITRACLIP NT CLIP DELIVERY SYSTEM |
| 08717648231025 | Steerable Guide Catheter |
| 08717648231001 | MitraClip G4 Clip Delivery System XTW |
| 08717648230981 | MitraClip G4 Clip Delivery System XT |
| 08717648230967 | MitraClip G4 Clip Delivery System NTW |
| 08717648230943 | MitraClip G4 Clip Delivery System NT |
Trademark Results [MITRACLIP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MITRACLIP 78503491 3259174 Live/Registered |
Evalve, Inc. 2004-10-21 |
 MITRACLIP 77772245 4042528 Dead/Cancelled |
Evalve, Inc. 2009-07-01 |
 MITRACLIP 77173529 3365396 Live/Registered |
Evalve, Inc. 2007-05-04 |
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