PROFLEX 5
Catheter, Angioplasty, Peripheral, Transluminal
PERIPHERAL SYSTEMS GROUP
The following data is part of a premarket notification filed by Peripheral Systems Group with the FDA for Proflex 5.
Pre-market Notification Details
| Device ID | K915168 |
| 510k Number | K915168 |
| Device Name: | PROFLEX 5 |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Linda Guthrie |
| Correspondent | Linda Guthrie PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-15 |
| Decision Date | 1992-02-19 |
Trademark Results [PROFLEX 5]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROFLEX 5 73706728 1578805 Dead/Cancelled |
ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1988-01-21 |
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