Fogarty 120803FSP
GUDID 50690103205249
Fogarty Embolectomy Catheter
Edwards Lifesciences LLC
Thrombectomy balloon catheter| Primary Device ID | 50690103205249 |
| NIH Device Record Key | e36971c7-eba9-4231-89bf-c79a8a0a8d61 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fogarty |
| Version Model Number | 120803FSP |
| Catalog Number | 120803FSP |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690103205244 [Primary] |
| GS1 | 50690103205249 [Package] Contains: 00690103205244 Package: SHIPPER [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193379
FDA Product Code
| DXE | Catheter, Embolectomy |
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 | 2020-09-23 |
| Device Publish Date | 2020-09-15 |
On-Brand Devices [Fogarty]
| 00690103177657 | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 3F 120CM |
| 00690103176186 | ARTERIAL EMBOLECTOMY CATHETER WITH GATE VALVE 2F 45CM |
| 00690103163223 | FOGARTY FORTIS ARTERIAL EMBOLECTOMY CATHETER 4F 80CM |
| 00690103043785 | FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER |
| 00690103043754 | FOGARTY OCCLUSION CATHETER 8/22F 80CM |
| 00690103043747 | FOGARTY OCCLUSION CATHETER 8/14F 80CM |
| 00690103043730 | FOGARTY OCCLUSION CATHETER 5F 40CM |
| 00690103043723 | FOGARTY OCCLUSION CATHETER 4F 40CM |
| 00690103043716 | FOGARTY OCCLUSION CATHETER 3F 40CM |
| 00690103043662 | FOGARTY BILIARY BALLOON PROBE 5F 40CM |
| 00690103043655 | FOGARTY BILIARY BALLOON PROBE 6F 23CM |
| 00690103043648 | FOGARTY BILIARY BALLOON PROBE 5F 23CM |
| 00690103043631 | FOGARTY VENOUS THROMBECTOMY CATHETER 8F 80CM |
| 00690103043624 | FOGARTY VENOUS THROMBECTOMY CATHETER 8/10F 80CM |
| 00690103043617 | FOGARTY VENOUS THROMBECTOMY CATHETER 6F 80CM |
| 00690103043600 | FOGARTY IRRIGATION CATHETER 6FR 80CM |
| 00690103043594 | FOGARTY IRRIGATION CATHETER 4F, 80CM |
| 00690103043587 | FOGARTY IRRIGATION CATHETER 10F, 23CM |
| 00690103043570 | FOGARTY GRAFT THROMBECTOMY CATHETER 6F 50CM |
| 00690103043563 | FOGARTY GRAFT THROMBECTOMY CATHETER, 5F 50CM |
| 00690103043556 | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 7F 80CM |
| 00690103043549 | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 6F 80CM |
| 00690103043532 | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 5.5F 80CM |
| 00690103043518 | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 4F 80CM |
| 00690103043501 | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 3F 80CM |
| 00690103043495 | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 6F 40CM |
| 00690103043488 | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 5.5F 40CM |
| 00690103043464 | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER, 4F 40CM |
| 00690103043457 | FOGARTY THRU-LUMEN EMBOLECTOMY CATHETER 3F 40CM |
| 00690103043440 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 100CM |
| 00690103043433 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 7F 80CM |
| 00690103043426 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 6F 80CM |
| 00690103043419 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 5F 80CM |
| 00690103043402 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 80CM |
| 00690103043396 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 80CM |
| 00690103043389 | CATH,FOGARTY ART EMB 2FR 60CM FLAT PACK W/NAT RUB LATEX,STER |
| 00690103043372 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 40CM |
| 00690103043365 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 40CM |
| 00690103043341 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 7F 80CM |
| 00690103043327 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 6F 80CM |
| 00690103043310 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 5F 80CM |
| 00690103043303 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 80CM |
| 00690103043297 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 80CM |
| 00690103043280 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 80CM |
| 00690103043273 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 2F 60CM |
| 00690103043266 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 4F 40CM |
| 00690103043259 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 40CM |
| 00690103043242 | FOGARTY ARTERIAL EMBOLECTOMY CATHETER 3F 40CM |
| 50690103205133 | FOGARTY BILIARY BALLOON PROBE 5F 40CM |
| 50690103205126 | FOGARTY BILIARY BALLOON PROBE 6F 23CM |
Trademark Results [Fogarty]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FOGARTY 87175386 not registered Dead/Abandoned |
Dunelm (Soft Furnishings) Limited 2016-09-19 |
 FOGARTY 85218443 4024207 Dead/Cancelled |
Fogarty Holdings Limited 2011-01-14 |
 FOGARTY 78152469 2865825 Dead/Cancelled |
Fogarty Holdings Limited 2002-08-08 |
 FOGARTY 73795379 not registered Dead/Abandoned |
COLOROLL HOME FURNISHINGS LIMITED 1989-04-24 |
 FOGARTY 73200045 1172120 Live/Registered |
American Hospital Supply Corporation 1979-01-15 |
 FOGARTY 72274724 0859124 Dead/Expired |
EDWARDS LABORATORIES, INC. 1967-06-26 |
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