Symphony™ 16F 82cm Catheter SYMPHONY16F82
GUDID 00850032079211
16F 82cm Symphony™ Catheter w/ Dilator
IMPERATIVE CARE, INC.
Thrombectomy suction catheter| Primary Device ID | 00850032079211 |
| NIH Device Record Key | a2f35eb4-0f2a-480a-b6fa-d47fad67649e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Symphony™ 16F 82cm Catheter |
| Version Model Number | SYMPHONY16F 82 |
| Catalog Number | SYMPHONY16F82 |
| Company DUNS | 080816678 |
| Company Name | IMPERATIVE CARE, 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
Device Dimensions
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
| Introducer Sheath Compatibilit | 16 French |
| Catheter Working Length | 82 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850032079211 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223216
FDA Product Code
| QEW | Peripheral Mechanical Thrombectomy With Aspiration |
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 | 2024-08-19 |
| Device Publish Date | 2024-08-09 |
Devices Manufactured by IMPERATIVE CARE, INC.
| 00812212030757 - Zoom 7X Catheter | 2025-06-17 Zoom 7X Catheter, 137cm |
| 00850032079211 - Symphony™ 16F 82cm Catheter | 2024-08-1916F 82cm Symphony™ Catheter w/ Dilator |
| 00850032079211 - Symphony™ 16F 82cm Catheter | 2024-08-19 16F 82cm Symphony™ Catheter w/ Dilator |
| 00812212030603 - Zoom™ 6F Insert Catheter, VTK | 2024-06-26 Zoom™ 6F Insert Catheter, VTK, 140cm |
| 00812212030627 - Zoom™ 6F Insert Catheter, VRT | 2024-06-26 Zoom™ 6F Insert Catheter, VRT, 137cm |
| 00812212030696 - Zoom™ 6F Insert Catheter, SIM | 2024-06-26 Zoom™ 6F Insert Catheter, SIM, 143cm |
| 00850032079174 - Symphony™ Advance™ Long Dilator | 2024-03-12 24F Symphony™ Advance™ Long Dilator |
| 10850032079164 - Symphony™ Clot Container | 2024-02-12 Symphony Clot Container |
| 00812212030573 - ZOOM™ 88 Large Distal Platform™ Support | 2023-06-12 ZOOM™ 88 088 LDP Support, 100 cm |
Trademark Results [Symphony]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYMPHONY 98487792 not registered Live/Pending |
BioSystems LLC 2024-04-07 |
 SYMPHONY 98487791 not registered Live/Pending |
BioSystems LLC 2024-04-07 |
 SYMPHONY 98138146 not registered Live/Pending |
Eastern Dairy Ltd. 2023-08-17 |
 SYMPHONY 97894721 not registered Live/Pending |
Arthrex, Inc. 2023-04-18 |
 SYMPHONY 97761106 not registered Live/Pending |
Smith & Nephew, Inc. 2023-01-19 |
 SYMPHONY 97690083 not registered Live/Pending |
Metacompliance Limited 2022-11-23 |
 SYMPHONY 97635897 not registered Live/Pending |
Aria Pharmaceuticals 2022-10-18 |
 SYMPHONY 97457398 not registered Live/Pending |
Panacea Products Corporation 2022-06-14 |
 SYMPHONY 97457143 not registered Live/Pending |
Panacea Products Corporation 2022-06-14 |
 SYMPHONY 97387275 not registered Live/Pending |
Bradley Kloss 2022-04-28 |
 SYMPHONY 97257934 not registered Live/Pending |
MLH MSO Holdco, Inc. 2022-02-08 |
 SYMPHONY 97213276 not registered Live/Pending |
46 Labs LLC 2022-01-11 |
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