VascuCel
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Admedus Regen Pty Ltd
The following data is part of a premarket notification filed by Admedus Regen Pty Ltd with the FDA for Vascucel.
Pre-market Notification Details
| Device ID | K162579 |
| 510k Number | K162579 |
| Device Name: | VascuCel |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| Applicant | Admedus Regen Pty Ltd 26 Harris Road Malaga, AU 6090 |
| Contact | Mary E. Donlin |
| Correspondent | Mary E. Donlin Admedus Corporation 860 Blue Gentian Road Ste 295 Eagan, MN 55121 |
| Product Code | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-15 |
| Decision Date | 2016-10-14 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348992000563 | K162579 | 000 |
| 09348992000532 | K162579 | 000 |
| 09348992000525 | K162579 | 000 |
| 09348992000693 | K162579 | 000 |
| 09348992000686 | K162579 | 000 |
| 09348992000679 | K162579 | 000 |
| 09348992000303 | K162579 | 000 |
| 09348992000273 | K162579 | 000 |
| 09348992000266 | K162579 | 000 |
Trademark Results [VascuCel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VASCUCEL 86770130 5080486 Live/Registered |
LEMAITRE VASCULAR, INC. 2015-09-28 |
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