HyperGlide
GUDID 00763000294533
BALLOON SYSTEM 104-4515 V20 HYPERGLIDE
Micro Therapeutics, Inc.
Intravascular occluding balloon catheter, image-guided| Primary Device ID | 00763000294533 |
| NIH Device Record Key | 41a93bc9-4d18-4628-a722-811aae6ca0fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HyperGlide |
| Version Model Number | 104-4515 |
| Company DUNS | 826110710 |
| Company Name | Micro Therapeutics, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *This device should be stored in a dry place at between 50°F (10°C) and 90°F (32°C). |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000294533 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K101570
FDA Product Code
| MJN | Catheter, intravascular occluding, temporary |
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 | 2020-08-10 |
| Device Publish Date | 2020-08-01 |
On-Brand Devices [HyperGlide]
| 00836462004580 | Occlusion Balloon System |
| 00836462004559 | Occlusion Balloon System |
| 00836462004542 | Occlusion Balloon System |
| 00836462004481 | Occlusion Balloon System |
| 00836462004467 | Occlusion Balloon System |
| 00836462004177 | Occlusion Balloon System |
| 00836462004146 | Occlusion Balloon System |
| 00836462004122 | Occlusion Balloon System |
| 00836462004115 | Occlusion Balloon System |
| 00763000294595 | BALLOON SYSTEM 104-4530 V20 HYPERGLIDE |
| 00763000294564 | BALLOON SYSTEM 104-4520 V20 HYPERGLIDE |
| 00763000294533 | BALLOON SYSTEM 104-4515 V20 HYPERGLIDE |
| 00763000294502 | BALLOON SYSTEM 104-4315 V20 HYPERGLIDE |
| 00763000294472 | BALLOON SYSTEM 104-4310 V20 HYPERGLIDE |
| 00763000294441 | BALLOON SYSTEM 104-4132 V20 HYPERGLIDE |
| 00763000294410 | BALLOON SYSTEM 104-4127 V20 HYPERGLIDE |
| 00763000294380 | BALLOON SYSTEM 104-4113 V20 HYPERGLIDE |
| 00763000294359 | BALLOON SYSTEM 104-4112 V20 HYPERGLIDE |
Trademark Results [HyperGlide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYPERGLIDE 90351538 not registered Live/Pending |
Covidien LP 2020-12-01 |
 HYPERGLIDE 90343360 not registered Live/Pending |
Hyperglide Mouse Skates 2020-11-25 |
 HYPERGLIDE 85624345 4519907 Live/Registered |
The King of Shaves Company Ltd. 2012-05-14 |
 HYPERGLIDE 85138583 not registered Dead/Abandoned |
The King of Shaves Company Ltd 2010-09-27 |
 HYPERGLIDE 78840911 3645024 Dead/Cancelled |
GT&S, Inc. 2006-03-20 |
 HYPERGLIDE 74015244 1622380 Live/Registered |
Shimano Industrial Company limited 1989-12-29 |
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