Progreat Lambda
Catheter, Intravascular, Diagnostic
Terumo Clinical Supply Co., Ltd.
The following data is part of a premarket notification filed by Terumo Clinical Supply Co., Ltd. with the FDA for Progreat Lambda.
Pre-market Notification Details
| Device ID | K211078 |
| 510k Number | K211078 |
| Device Name: | Progreat Lambda |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Terumo Clinical Supply Co., Ltd. 3, Kawashima-Takehayamachi Kakamigahara, JP 501-6024 |
| Contact | Vaibhav Sivaramakrishan |
| Correspondent | Vaibhav Sivaramakrishan Terumo Medical Corporation 265 Davidson Ave., Suite 320 Somerset, NJ 08873 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-12 |
| Decision Date | 2021-12-21 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54987350741023 | K211078 | 000 |
| 54987350741009 | K211078 | 000 |
| 04987350740984 | K211078 | 000 |
Trademark Results [Progreat Lambda]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROGREAT LAMBDA 88464196 not registered Live/Pending |
Terumo Kabushiki Kaisha 2019-06-07 |
 PROGREAT LAMBDA 88464154 not registered Live/Pending |
Terumo Kabushiki Kaisha 2019-06-07 |
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