INVISIPORT
Port & Catheter, Implanted, Subcutaneous, Intravascular
STEALTH THERAPEUTICS, INCORPORATED
The following data is part of a premarket notification filed by Stealth Therapeutics, Incorporated with the FDA for Invisiport.
Pre-market Notification Details
| Device ID | K141146 |
| 510k Number | K141146 |
| Device Name: | INVISIPORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | STEALTH THERAPEUTICS, INCORPORATED 800 LEVANGER LANE Stoughton, WI 53589 |
| Contact | Gary Syring |
| Correspondent | Gary Syring STEALTH THERAPEUTICS, INCORPORATED 800 LEVANGER LANE Stoughton, WI 53589 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-05 |
| Decision Date | 2015-05-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864144000209 | K141146 | 000 |
Trademark Results [INVISIPORT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INVISIPORT 77534511 4158060 Live/Registered |
Stealth Therapeutics, Inc. 2008-07-30 |
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